(88 days)
87 KWQ, KWO
K/DEN number and list them here in a comma separated list exactly as they appear in the text:
Not Found
No
The provided text describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as a "Cervical Spinal System" intended for "anterior intervertebral body screw fixation of the cervical spine" to provide "temporary stabilization" and aid in "cervical spine fusions" for various conditions like degenerative disc disease, trauma, tumors, and deformity. These indications clearly point to its use in treating medical conditions.
No
The document describes a spinal fixation system (plates and screws) used for stabilization and fusion of the cervical spine. Its purpose is mechanical support, not to diagnose a condition.
No
The device description clearly states that the system includes physical components such as plates and screws, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The provided text clearly describes a surgical implant system (plates and screws) intended for fixation within the cervical spine. This is a device used inside the body (in vivo) for structural support and stabilization.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
This device is a surgical implant used for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spinal Innovations SPECTRUM™ Cervical Spinal System is intended for anterior intervertebral body screw fixation of the cervical spine. The system implants are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes
87 KWQ, KWO
Device Description
The Spinal Innovations SPECTRUM™ Cervical Spinal System is intended for anterior intervertebral body screw fixation of the cervical spine. This system includes plates in varying designs and both fixed angle and variable angle screws. The screws are available in diameters of 4.0 mm and 4.5 mm and varying lengths. The plates have two widths: Standard width of .750 inches and Narrow width of .680 inches. The plates will be available in two lordotic curve geometries. The Cervical Screws are cancellous bone screws. The screw locking means is assembled to the plate during the manufacturing process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
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
Biomechanical testing demonstrated that the components of the Spinal Innovations SPECTRUM™ Cervical Spinal System exhibit equivalent mechanical performance, compared to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Sofamor Danek Orion™ Anterior Cervical Plate System, Sofamor Danek Atlantis™ Anterior Cervical Plate System, Medtronic Sofamor Danek Zephir™ Anterior Cervical Plate System, Synthes Cervical Spine Locking Plate System, and
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 0 6 2002
510 (K) Summary of Safety and Effectiveness
| Company Name: | Spinal Innovations, Inc.
7850 Stage Hills Blvd.
Suite 105
Bartlett, TN 38133
(901) 373-8855
(901) 373-8303 fax |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Joseph S. Clift
Vice President of Regulatory
And Clinical Affairs
(901) 373-8855 |
| Trade Name: | Spinal Innovations SPECTRUM™
Cervical Spinal System |
| Common Name: | Plate and Screw Cervical Spinal
Fixation System |
| Classification: | 888.3060 Spinal Intervertebral Body
Fixation Orthosis - classII |
| Device Product Code: | 87 KWQ |
| Predicate Devices: | Sofamor Danek Orion™ Anterior
Cervical Plate System,
Sofamor Danek Atlantis™ Anterior
Cervical Plate System,
Medtronic Sofamor Danek Zephir™
Anterior Cervical Plate System,
Synthes Cervical Spine Locking
Plate System, and |
Device Description
The Spinal Innovations SPECTRUM™ Cervical Spinal System is intended for anterior intervertebral body screw fixation of the cervical spine. This system includes plates in varying designs and both fixed angle and variable angle screws. The screws are available in diameters of 4.0 mm and 4.5 mm and varying lengths. The plates have two widths: Standard width of .750 inches and Narrow width of .680 inches. The plates will be available in two lordotic curve geometries. The Cervical Screws are cancellous bone screws. The screw locking means is assembled to the plate during the manufacturing process.
1
Intended Use
The Spinal Innovations SPECTRUM™ Cervical Spinal System is intended for anterior intervertebral body screw fixation of the cervical spine. The system implants are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Testing
Biomechanical testing demonstrated that the components of the Spinal Innovations SPECTRUM™ Cervical Spinal System exhibit equivalent mechanical performance, compared to predicate devices.
Basis for Substantial Equivalence
The Spinal Innovations SPECTRUM™ Cervical Spinal System is substantially equivalent in material, design and function to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the circumference of the circle. The text is written in all capital letters.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0 6 2002
Mr. Joseph S. Clift Vice President, Regulatory Affairs Spinal Innovations. Inc. 7850 Stage Hill Blvd Suite 105 Bartlett, Tennessee 38133
K022997 Re:
Trade Name: SPECTRUM™ Cervical Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Fixation Orthosis Regulatory Class: II Product Code: KWO Dated: September 6, 2002 Received: September 9, 2002
Dear Mr. Clift:
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. Iisting 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.
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Page 2 - Mr. Joseph S. Clift
This letter will allow you to begin marketing your device as described in your Section 510(k). premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
O Mark M. Millan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K022997 510(K) Number
Device Name: Spinal Innovations SPECTRUM™ Cervical Spinal System.
Indications for Use:
The Spinal Innovations SPECTRUM TM Cervical Spinal System is intended for anterior intervertebral body screw fixation of the cervical spine. The system implants are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
for
(Division Sign-Off)
Mark N. Milliman
Division of General, Restorative and Neurological Devices
510(k) Number K022997
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)