(128 days)
Not Found
No
The summary describes a mechanical fixation system with no mention of AI/ML, image processing, or data-driven performance metrics.
No
The device is described as a fixation system for laminoplasty procedures, designed to hold allograft material in place. It's a mechanical support device, not one intended to diagnose, cure, mitigate, treat, or prevent disease, or affect the structure or any function of the body in a therapeutic manner.
No
This device is a fixation system used in surgical procedures (laminoplasty) to hold allograft material in place, not to diagnose a condition.
No
The device description explicitly states it consists of "different sizes of plates and screws," which are hardware components, not software.
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 Description and Intended Use: The NuVasive Laminoplasty Fixation System is a surgical implant (plates and screws) used to fix allograft material in place during a laminoplasty procedure in the spine. It is a physical device used in the body, not a test performed on samples from the body.
The information provided clearly describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The NuVasive Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Laminoplasty Fixation System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.
Product codes
NQW
Device Description
The NuVasive Laminoplasty Fixation System consists of different sizes of plates and screws that can be rigidly locked 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
lower cervical and upper thoracic spine (C3 to T3)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Mechanical testing was presented.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
Onuvasive
510(k) Premarket Notification Laminoplasty Fixation System
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
Ms. Han Fan Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Boulevard San Diego, California 92121 Telephone: (858) 909-3338 Fax: (858) 909-3438
OCT - 9 2009
B. Device Name
| Trade or Proprietary Name: | NuVasive Laminoplasty Fixation System |
|---|---|
| Common or Usual Name: | Interlaminal Fixation Appliance |
| Classification Name: | Spinal Interlaminal Fixation Orthosis |
| Device Class: | Class II |
| Classification: | §888.3050 |
| Product Code: | NQW |
C. Predicate Devices
The subject device is substantially equivalent to similar previously cleared device. Synthes's Arch™ System (K032534) that is currently distributed commercially in U.S.
D. Device Description
The NuVasive Laminoplasty Fixation System consists of different sizes of plates and screws that can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.
E. Intended Use
The NuVasive Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Laminoplasty Fixation System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.
F. Substantial Equivalence
Data was provided which demonstrated the NuVasive Laminoplasty System 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).
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three wing-like shapes, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
NuVasive, Incorporated % Ms. Han Fan Regulatory Affairs Specialist 7475 Lusk Boulevard San Diego, California 92121
Re: K091623
Trade/Device Name: NuVasive® Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: NOW Dated: September 25, 2009 Received: September 28, 2009
OCT - 9 2009
Dear Ms. Fan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 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 (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.
2
Page 2 – Ms. Han Fan
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/MedicalDevices/ResourcesforYou/Industry/defaulthtm.
Sincerely yours,
Mark N. Melkers Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosurc
3
- INDICATIONS FOR USE
510(k) Number (if known): K091623
Device Name: NuVasive® Laminoplasty Fixation System
Indications for Use:
The NuVasive Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Laminoplasty Fixation System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.
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)
vice Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number /K09/623