(57 days)
Not Found
No
The description focuses on mechanical and magnetic mechanisms for spinal distraction and bracing, with no mention of AI or ML.
Yes
The device is described as a "Spinal Bracing and Distraction System" intended to correct severe progressive spinal deformities and prevent Thoracic Insufficiency Syndrome (TIS), which directly addresses a health condition.
No
The device is a surgical implant and associated external controller used for spinal bracing and mechanical distraction to treat severe progressive spinal deformities in skeletally immature patients. While used in the context of a diagnosis (severe progressive spinal deformities), the device itself is a therapeutic device and not a diagnostic one, as it does not identify or characterize a medical condition.
No
The device description clearly outlines multiple hardware components including a surgically implanted spinal rod, an external remote controller (ERC), a manual distractor, and a magnet locator. The software component, if any, would be part of the ERC, but the system is fundamentally hardware-based.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Ellipse MAGEC 2 Spinal Bracing and Distraction System is a surgically implanted device used to physically brace and distract the spine. It is a mechanical device that directly interacts with the patient's anatomy.
- Lack of Sample Analysis: The device does not analyze any biological samples from the patient. Its function is entirely based on mechanical manipulation of the spine.
The description clearly indicates it's a surgical implant and associated external components used for physical intervention on the spine, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Ellipse MAGEC 2 Spinal Bracing and Distraction System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth.
Product codes (comma separated list FDA assigned to the subject device)
PGN
Device Description
The MAGEC 2 Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia9 fixation components (i.e. Pedicle screws, hooks and/or connectors). The implanted MAGEC 2 rod is used to brace the spine during growth to minimize the progression of scoliosis. The system includes a non-sterile hand held External Remote Controller (ERC or ERC 2) that is used periodically after implantation to noninvasively distract the implanted spinal rod. The titanium MAGEC 2 rod includes an actuator portion that holds a small internal magnet. The magnet in the actuator can be turned non-invasively by use of the ERC, which is electrically powered. The hand held non-invasive ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and distract the MAGEC 2 rod. Once the physician determines that the implant has achieved its intended use and is no longer required, the implant is explanted. Additional accessories for the MAGEC 2 System include the MAGEC Manual Distractor and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterile, single use device, which is used in the operating room to test the MAGEC 2 rod prior to implantation. The MAGEC Manual Distractor used with the MAGEC 2 System is made of Radel® and contains a rare-earth magnet. The MAGEC Wand Magnet Locator is a non-sterile device which is used during the distraction procedure to locate the magnet within the MAGEC 2 rod. The ERC is placed over this location on the child's back.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, Thoracic spine
Indicated Patient Age Range
skeletally immature patients less than 10 years of age
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing on the MAGEC 2 System included Static and Dynamic Mechanical testing according to the methods outlined in the standard ASTM F1717, wear testing and particulate analysis according to the methods in the standards ASTM F2624 and ASTM F1877, validation of the gamma radiation sterilization cycle in accordance with the VDmag 22 methodology as given in ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 10-6 and design verification and validation. Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate.
Previous clinical performance data for the predicate MAGEC System is applicable to the MAGEC 2 System. The safety and probable benefit of the predicate MAGEC System was evaluated outside the United States in a retrospective clinical study for children who had either a primary or revision spinal bracing procedure using the MAGEC System. In assessing probable benefit, the endpoints chosen in the study included Cobb angle correction in the coronal plane, thoracic spine height increase, improvement in space available for lung (SAL), coronal and sagittal balance, reduction in the number of subsequent surgical procedures, and weight gain.
The results of the clinical study showed the MAGEC System provides the benefits of spinal deformity correction and continued growth, similar to that for traditional growing rods, without the need for regular surgical lengthening procedures in these children. As with traditional growing rods, the MAGEC System provides direct bracing to the spine. This bracing provides for correction and maintenance of the scoliotic curve as defined by the Cobb Angle. In addition, a return to a more normal symmetry of the thoracic cavity is provided as demonstrated by the space available for lung (SAL). While implantation of the MAGEC System shares many of the same risks and hazards associated with those of traditional growing rods, the MAGEC System offers the benefit of non-invasive adjustment to lengthen the implanted rod without the need to perform another surgery. The ability of the device to be adjusted non-invasively in length provides the ability of the spine to continue growing in these subjects and for the Thoracic Spine Height to increase with this growth.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MAGEC Spinal Bracing and Distraction System, K140613
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
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July 29, 2022
Ellipse Technologies, Incorporated Rebecca Shelburne Regulatory Affairs Project Manager 13900 Alton Parkway Suite 123 Irvine, California 92618
Re: K150885
Trade/Device Name: MAGEC® 2 Spinal Bracing and Distraction System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: PGN
Dear Rebecca Shelburne:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 29, 2015. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under regulation number, 21 CFR 888.3070.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ronald Jean, OHT6: Office of Orthopedic Devices, (301)796-5650, Ronald.Jean@fda.hhs.gov.
Sincerely,
Ronald P. Jean -S
Ronald P. Jean, Ph.D. Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 29, 2015
Ellipse Technologies, Incorporated Ms. Rebecca Shelburne Regulatory Affairs Project Manager 13900 Alton Parkway Suite 123 Irvine, California 92618
Re: K150885
Trade/Device Name: MAGEC 2 Spinal Bracing and Distraction System Regulatory Class: Unclassified Product Code: PGN Dated: April 1, 2015 Received: April 2, 2015
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041
2
Page 2 – Ms. Rebecca Shelburne
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K150885
Device Name
MAGEC 2 Spinal Bracing and Distraction System
Indications for Use (Describe)
The Ellipse MAGEC 2 Spinal Bracing and Distraction System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/1 description: The image shows the logo for Ellipse. The logo consists of three overlapping circles on the left and the word "ELLIPSE" in a bold, sans-serif font on the right. The circles are in shades of blue and green, while the word "ELLIPSE" is in a dark blue color.
13900 Alton Parkway, Suite 123 Irvine, California 92618 USA Office: 949-837-3600 949-837-3664 Fax: www.ellipse-tech.com
510(k) Summary
MAGEC® 2 Spinal Bracing and Distraction System
Premarket Notification Number: K150885
| 1. | Company: | Ellipse Technologies, Incorporated
13900 Alton Parkway, Suite 123
Irvine, CA 92618 |
|----|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | Contact: | Rebecca Shelburne
Regulatory Affairs Project Manager
Phone: (949) 837-3600 x227
Fax: (949) 837-3664 |
| | Date Prepared: | April 2, 2015 |
| 2. | Proprietary Trade Name: MAGEC® 2 Spinal Bracing and Distraction System | |
| 3. | Common Name: | Non Fusion Growing Rod System |
- Classification Name: Unclassified (Product Code PGN, Growing Rod System - Magnetic 4. Actuation)
- న్. Primary Predicate: MAGEC Spinal Bracing and Distraction System, K140613
Product Description: The MAGEC 2 Spinal Bracing and Distraction System is comprised of a 6. sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia9 fixation components (i.e. Pedicle screws, hooks and/or connectors). The implanted MAGEC 2 rod is used to brace the spine during growth to minimize the progression of scoliosis. The system includes a non-sterile hand held External Remote Controller (ERC or ERC 2) that is used periodically after implantation to noninvasively distract the implanted spinal rod. The titanium MAGEC 2 rod includes an actuator portion that holds a small internal magnet. The magnet in the actuator can be turned non-invasively by use of the ERC, which is electrically powered. The hand held non-invasive ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and distract the MAGEC 2 rod. Once the physician determines that the implant has achieved its intended use and is no longer required, the implant is explanted. Additional accessories for the MAGEC 2 System include the MAGEC Manual Distractor and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterile, single use device, which is used in the operating room to test the MAGEC 2 rod prior to implantation. The MAGEC Manual Distractor used with the MAGEC 2 System is made of Radel® and contains a rare-earth
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K150885 - Page 2 of 4
13900 Alton Parkway, Suite 123 Irvine, California 92618 US Office: 949-837-3600 949-837-3664 www.ellipse-tech.com
magnet. The MAGEC Wand Magnet Locator is a non-sterile device which is used during the distraction procedure to locate the magnet within the MAGEC 2 rod. The ERC is placed over this location on the child's back.
Indications for Use: The Ellipse MAGEC 2 Spinal Bracing and Distraction System is 7. intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth.
- Substantial equivalence: Documentation that includes mechanical test results, design verification and detailed comparison to the predicate device demonstrates that the MAGEC 2 System is substantially equivalent to the following 510(k) cleared device:
- MAGEC Spinal Bracing and Distraction System (K140613) ●
Substantial equivalence to the predicate device is based on indications for use, principles of operation, technological characteristics, and pre-clinical testing performed.
The MAGEC 2 System that is subject of this premarket notification and the predicate device have the same indications for use. Both the MAGEC 2 System and the predicate device are spinal rods that have adjustable length, and are implanted on the posterior spine using hooks or screws. Both devices operate on the same non-invasive distraction technology using the Ellipse External Remote Controller (ERC or ERC 2). The technological characteristics of the subject device and the predicate device are similar. Both systems are manufactured of the same biocompatible metals and supplied sterile by the same methods of gamma radiation. The differences between the two systems include the addition of a 6.0 mm diameter rod to the product offering, design modifications to remove structural welds and new design features.
Non-clinical testing on the MAGEC 2 System included Static and Dynamic Mechanical testing according to the methods outlined in the standard ASTM F1717, wear testing and particulate analysis according to the methods in the standards ASTM F2624 and ASTM F1877, validation of the gamma radiation sterilization cycle in accordance with the VDmag 22 methodology as given in ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 106 and design verification and validation. Results of these tests demonstrate that there are no new risks associated with the device and the device can be expected to perform in a manner substantially equivalent to the predicate.
6
K150885 - Page 3 of 4
Image /page/6/Picture/1 description: The image shows the logo for Ellipse. The logo consists of a circular design on the left and the word "ELLIPSE" on the right. The circular design is made up of three overlapping circles in shades of blue and green. The word "ELLIPSE" is written in a bold, sans-serif font in a dark blue color.
13900 Alton Parkway, Suite 123 Irvine, California 92618 USA Office: 949-837-3600 949-837-3664 www.ellipse-tech.com
The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include:
| Test Description | Applicable Test Standard |
|---|---|
| Static Mechanical Testing | ASTM F1717-14 |
| Dynamic Mechanical Testing | ASTM F1717-14 |
| Wear Testing | ASTM F2624-12 |
| Particulate Analysis | ASTM F1877-05 |
| Sterilization Validation | ANSI/AAMI/ISO 11137-2 |
| Design Verification | None |
Additional non-clinical tests that were performed on the predicate MAGEC System are also applicable to the MAGEC 2 System with the design modifications and additional diameter rod. The performance testing on the predicate device includes, shelf life testing, and biocompatibility in accordance with ISO 10993-1 for the intended use of the device. There are no changes to the ERC being made as a result of this submission, therefore all testing that was performed on the predicate MAGEC System for the ERC are applicable to the MAGEC 2 System subject of this premarket notification.
9. Clinical Performance Data:
Previous clinical performance data for the predicate MAGEC System is applicable to the MAGEC 2 System. The safety and probable benefit of the predicate MAGEC System was evaluated outside the United States in a retrospective clinical study for children who had either a primary or revision spinal bracing procedure using the MAGEC System. In assessing probable benefit, the endpoints chosen in the study included Cobb angle correction in the coronal plane, thoracic spine height increase, improvement in space available for lung (SAL), coronal and sagittal balance, reduction in the number of subsequent surgical procedures, and weight gain.
The results of the clinical study showed the MAGEC System provides the benefits of spinal deformity correction and continued growth, similar to that for traditional growing rods, without the need for regular surgical lengthening procedures in these children. As with traditional growing rods, the MAGEC System provides direct bracing to the spine. This bracing provides for correction and mantenance of the scoliotic curve as defined by the Cobb Angle. In addition, a return to a more normal symmetry of the thoracic cavity is provided as demonstrated by the space available for lung (SAL). While implantation of the MAGEC System shares many of the same risks and hazards associated with those of traditional growing rods, the MAGEC System offers the benefit of non-invasive adjustment to lengthen the implanted rod without the need to perform another surgery. The ability of the device to be adjusted non-invasively in
7
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13900 Alton Parkway, Suite 123 Irvine, California 92618 USA Office: 949-837-3600 949-837-3664 Fax: www.ellipse-tech.com
length provides the ability of the spine to continue growing in these subjects and for the Thoracic Spine Height to increase with this growth.
10. Conclusion:
Conclusions can be drawn from these tests that the MAGEC 2 System is substantially equivalent to the predicate device.