Sulzer Spine-Tech
Country not established
- Devices
- 8
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Sulzer Spine-Tech makes
Sulzer Spine-Tech manufactures spinal fixation systems, including the Silhouette and Cadence systems for internal spinal stabilization, as well as modifications to these platforms. Their portfolio also includes anterior cervical plate systems like Trinica, interbody fusion devices (BAK/Cervical), and a titanium cement restrictor (RPX) for spinal procedures. These products are designed for surgical applications in spinal stabilization and fusion.
The company’s devices are classified under FDA Class II and are authorised via 510(k) clearances and PMA submissions. Their products are listed in the FDA’s regulatory records, and the company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Silhouette Spinal Fixation System Ref K993067
Regimes: 510(k) Registry: 510(k)Cadence Spinal Fixation System Ref K022374
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Rpx Titanium Cemnt Restrictor Ref K020344
Regimes: 510(k) Registry: 510(k)Bak/Cervical (Bak/C) (R) Interbody Fusion System Ref P980048
Regimes: PMA Registry: PMA
FDA recalls
FDA recall records list 1 recall initiated by Sulzer Spine-Tech, initiated on 2003-01-17. 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.
2003
- 17 Jan 2003 Z-0559-03 Unclassified (pre-2012) Terminated With 14 units distributed, there have been 10 complaints of the product having a twisted or broken tip.
Full distribution text
- 17 Jan 2003 Z-0559-03 Unclassified (pre-2012) Terminated With 14 units distributed, there have been 10 complaints of the product having a twisted or broken tip.
Frequently asked questions
How many devices does Sulzer Spine-Tech have in the registry?
The registry currently lists 8 devices for Sulzer Spine-Tech. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sulzer Spine-Tech's devices?
Among its 8 most recently registered devices, Sulzer Spine-Tech has devices listed in FDA 510(k) (7 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sulzer Spine-Tech's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Sulzer Spine-Tech's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Sulzer Spine-Tech?
FDA recall records list 1 recall initiated by Sulzer Spine-Tech, the most recent initiated on 17 Jan 2003. 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 Sulzer Spine-Tech in the registry?
The most recently registered devices listed for Sulzer Spine-Tech include MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM, SILHOUETTE SPINAL FIXATION SYSTEM, CADENCE SPINAL FIXATION SYSTEM and MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM.