(45 days)
Not Found
Not Found
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for the treatment of various spinal instabilities and conditions, including fractures, tumors, degenerative disc disease, and deformities, which are therapeutic interventions.
No
Explanation: The device is an implant system (plates, screws, bolts, and locking nuts) used for surgical stabilization of the spine. Its indicated uses are treatments for instability due to various conditions, not for diagnosing them.
No
The device description explicitly states it consists of plates, screws, bolts, and nuts, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant system for stabilizing the spine in various conditions. This is a therapeutic device used in vivo (within the body).
- Device Description: The description details plates, screws, bolts, and nuts, which are physical components for surgical implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to diagnose diseases or conditions in vitro (outside the body).
Therefore, the NuVasive Lateral Plate System is a surgical implant device, not an IVD.
N/A
Intended Use / 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), 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.
Product codes
KWO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
thoracic and thoracolumbar (T1-L5) spine, lumbar and lumbosacral (L1-S1) 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests: Mechanical testing was presented.
Summary of Clinical Tests: (Not Applicable).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the logo for NUVASIVE. The logo features a stylized arc above the letters "NU" and the rest of the company name in all caps. Below the company name is some smaller text that is illegible.
K061789 (pg 1 of 2)
510(k) Premarket Notification
Lateral Plate System
AUG 1 0 2006
5. 510(K) SUMMARY
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness 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 Common or Usual Name: Spinal Implants Classification Name: Spinal Intervertebral Body Fixation orthosis. Device Class: Class II Classification: $888.3060 Product Code: KWO
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 lumborsacral (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.
1
NUVASIVE
510(k) Premarket Notification
Lateral Plate System
F. Substantial Equivalence
Data was provided which demonstrated the NuVasive Lateral Plate to be substantially equivalent to previously cleared devices. The substantial equivalence is bastd upon equivalence in indications for use, design, material, and function.
-
G. Summary of Non-Clinical Tests Mechanical testing was presented.
Kob 1789 -
H. Summary of Clinical Tests (Not Applicable).
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 2006
NuVasive, Inc. c/o Ms. Laetitia Cousin Director of Regulatory Affairs and Quality Assurance 4545 Towne Center Court San Diego, CA 92121
Re: K061789
Trade Name: NuVasive Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: K WQ Dated: June 23, 2006 Received: June 26, 2006
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
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Page 2 - Ms. Laetitia Cousin
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.
Sincerely yours,
Barbara Buelno
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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4. INDICATIONS FOR USE
510(k) Number (if known):
Device Name: NuVasive Lateral Late 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), 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.
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)
| Barbara Buchholz for pam | |
|---|---|
| -- | -------------------------- |
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K061789 |
|---|---|
| --------------- | --------- |