(64 days)
The NuVasive Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
The NuVasive Lateral Plate System consists of a variety of plates, screws, bolts, and locking nuts. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.
The provided text describes a 510(k) premarket notification for the NuVasive Lateral Plate System, which is a medical device. This document does not contain information about software with acceptance criteria, reported device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document pertains to a physical medical device (spinal implants) and focuses on demonstrating substantial equivalence to previously cleared devices through mechanical testing and comparison of indications for use, design, material, and function. There is no mention of an AI/ML device or software in this submission.
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Image /page/0/Picture/0 description: The image contains the logo for NUVASIVE. The logo features a stylized graphic to the left of the word "NUVASIVE" in a bold, sans-serif font. Below the company name, there is a tagline that reads "Creative Spine Technology" in a smaller, italicized font.
VII. 510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular $807.92, the following summary of information is provided:
A. Submitted by
Laetitia Cousin 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 Lateral Plate System Spinal Implants Common or Usual Name: Classification Name: Spinal Intervertebral Body Fixation orthosis. Device Class: Class II 888.3060 Classification: KWQ Product Code:
C. Predicate Devices
The subject device is substantially equivalent to similar previously cleared devices.
D. Device Description
The NuVasive Lateral Plate System consists of a variety of plates, screws, bolts, and Implant components can be rigidly locked to suit the individual locking nuts. pathology and anatomical conditions of the patient.
E. Intended Use
The NuVasive Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
APR - 3 2007
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F. Substantial Equivalence
K070273
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Data was provided which demonstrated the NuVasive Lateral Plate to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function.
G. Summary of Non-Clinical Tests
Mechanical testing was presented.
- H. Summary of Clinical Tests (Not Applicable).
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and governmental nature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NuVasive, Incorporated c/o Ms. Laetitia Cousin Director of Regulatory Affairs and Quality Assurance 4545 Towne Centre Court San Diego, California 92121
APR - 3 2007
Re: K070273
Trade/Device Name: Nuvasive Lateral Plate System Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: March 02, 2007 Received: March 05, 2007
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.
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Page 2 - Ms. Laetitia Cousin
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.
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Buchner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Ko 70273
Device Name: Lateral Plate System
Indications For Use:
The NuVasive Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.
Prescription Use (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)
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Chailane Burch
Division of General, Restorative and Neurological Devices
510(k) Number K070273
§ 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.