Spine Smith Partners L.P.
United StatesFDA applicant, unverified
- Devices
- 9
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Spine Smith Partners L.P. makes
Spine Smith Partners L.P. manufactures spinal fixation systems, including anterior cervical plates, interbody fusion implants, and challenging-access plates designed for surgical spinal stabilization. Their portfolio includes modular spinal systems like the Cynch and Cimplicity, as well as specialized tools such as the Visualif system for enhanced surgical access. These devices are intended for procedures addressing degenerative disc disease, spinal deformities, and trauma-related instability.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. Their products are listed in the FDA’s 510(k) registry, reflecting compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Spinesmith Cynch Spinal System Ref K090376
Regimes: 510(k) Registry: 510(k)Spinesmith Cynch Spinal System Ref K101085
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Visualif Challenging Access Plate Ref K122168
Regimes: 510(k) Registry: 510(k)Cimplicity Spinal System Ref K073320
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Spinesmith Cimplicity Spinal System Ref K080971
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
IN:C2 Spinal Fixation System Ref K122630
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Spine Smith Partners L.P., initiated on 2012-08-24. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 24 Aug 2012 Z-0932-2013 Class II Terminated Implants were incorrectly laser marked as 23mm instead of 28mm.
Frequently asked questions
How many devices does Spine Smith Partners L.P. have in the registry?
The registry currently lists 9 devices for Spine Smith Partners L.P.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spine Smith Partners L.P.'s devices?
Among its 9 most recently registered devices, Spine Smith Partners L.P. has devices listed in FDA 510(k) (9 devices).
What risk classes do Spine Smith Partners L.P.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Spine Smith Partners L.P.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Spine Smith Partners L.P.?
FDA recall records list 1 recall initiated by Spine Smith Partners L.P., the most recent initiated on 24 Aug 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Spine Smith Partners L.P. in the registry?
The most recently registered devices listed for Spine Smith Partners L.P. include SPINESMITH CYNCH SPINAL SYSTEM, SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM, VISUALIF CHALLENGING ACCESS PLATE and CIMPLICITY SPINAL SYSTEM.