(119 days)
Not Found
No
The provided text describes a mechanical implant for vertebral body replacement and does not mention any AI or ML components or functionalities.
Yes
The device is a partial vertebral body replacement indicated for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma, and to achieve decompression of the spinal cord and neural tissues, which directly addresses a medical condition to restore function.
No
The device description indicates that the NuVasive CoRoent ExtenSure System is an implantable vertebral body replacement device used for treatment, not for diagnosis.
No
The device description explicitly states it is an "implantable PEEK vertebral body replacement device," which is a physical hardware component, not software.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The NuVasive CoRoent ExtenSure System is an implantable vertebral body replacement device. Its purpose is to physically replace a damaged or diseased part of the spine. It does not perform any tests on bodily samples.
The description clearly indicates it's a surgical implant used for structural support and decompression, which falls under the category of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The NuVasive CoRoent ExtenSure System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The NuVasive CoRoent ExtenSure System is an implantable PEEK vertebral body replacement device indicated for use in the thoracic and lumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues.
The device is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and lumbar spine (i.e., T1 to L5)
Indicated Patient Age Range
Not Found
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)
Mechanical testing was presented.
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.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
K052210
Page 1 of 2
DEC 1 2 2005
VII. 510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular
in the Collection of information in provided: in accordance while wing summary of information is provided:
Submitted by: A.
Laetitia Cousin Eachtra Coubin
Director of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, California 92121 Telephone: (858) 909-1868 Fax: (858) 909-2068
B. Device Name
| Trade or Proprietary Name: | NuVasive CoRoent ExtenSure System |
|---|---|
| Common or Usual Name: | Vertebral Body Replacement Device |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Device Class: | Class II |
| Classification: | $888.3060 |
| Product Code: | MQP |
Predicate Devices C.
The subject CoRoent ExtenSure System is substantially equivalent to the CoRoem System The subject Concent Extensure Bystem is Bussainting "The U.S. by NuVasive (K043205).
currently manufactured and distributed commercially in the U.S. by NuVasive (K043205).
1
K052210 Page 2 of 2
Device Description D.
The NuVasive CoRoent ExtenSure System is an implantable PEEK vertebral body replacement device indicated for use in the thoracic and lumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, replace a diseased vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues.
The device is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
E. Intended Use
The NuVasive CoRoent ExtenSure System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body murcated for use in the the the the treatment of a collapsed, or unstable vertebral body(s) resected of enched for and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are The Official is internative vee in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
Comparison to Predicate Devices F.
The subject device has indications for use identical to those of its predicate, and employs the same principles of operation.
Summary of Non-Clinical Tests G.
Mechanical testing was presented.
Summary of Clinical Tests H.
(Not Applicable).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
DEC 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Inc. 4545 Towne Centre Court San Diego, California 92121
Re: K052210
Trade/Device Name: NuVasive CoRoent™ ExtenSure™ System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: October 20, 2005 Received: November 15, 2005
Dear Ms. Cousin:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Ms. Laetitia Cousin
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your government of your device to a legally
premarket notification. The FDA finding of substantial equirales of your device to premarket notification. The PDA inding of substantal equived. Provins your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please ff you desire specific advice for your uc nee on one and the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note the regulation in contact the Office of Compliatice at (240) 270 v 1200 fra Part 807.97). You may obtain
"Misbranding by reference to premarket notification in the Division of Small "Misbranding by reference to premarkst notificas under the Act from the Division of Small
other general information on your responsibilities under the Act from pumber (800) 6 other general information on your responsion.com its toll-free number (800) 638-2041 or 2010) Manufacturers, International and Consumer Assistance as to version industry/support/index.html.
Sincerely yours,
Mark N. Melamed
Sor Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K052210
Device Name:____CoRoent™ ExtenSure™ System
Indications For Use:
The NuVasive CoRoent ExtenSure System is a partial vertebral body replace a diseased vertebral The NuVasive CoRoent Extenstite (T1 to L5) to replace a diseased vertebral
indicated for use in the thoracolumbar spines of damaned, or unstable vertebral indicated for use in the thoracountible (1) its to to to top do maged, or unstable vertebral body resected or excised for the ireathern of a collepos, casing of the spinal cord and
body(s) due to tumor or trauma and to achieve decompression of the mall spinal body(s) due to tumor of traunia and to be used with supplemental internal spinal neural tissues. The System the the FDA for use in the thoracic and lumbar spine.
fixation systems that are cleared by the FDA for use in the thoracy and lumbar spine.
Tixatio fixation systems that alle cleared by the FBF interest surgeon's discretion.
Allograft or autograft material may be used at the surgeon's discretion.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_""____________________________________________________________________________________________________________________________________________________________