Spine Wave, Inc.
United Statesfrom the FDA registration address FDA FEI 3004638600
Spine Wave, Inc. is a medical device manufacturer, with 3,823 devices listed and 3 FDA recalls as of 12 Nov 2026.
- Devices
- 3,823
- Registrations
- FDA
- FDA recalls
- 3
Registry facts
- Registries
- FDA GUDID 2,998
- FDA 510(k) 4
- Device classes
- FDA Class II 2,768
- FDA Class I 232
- FDA recalls
- Identifiers
- FDA FEI 3004638600
- DUNS 067789763
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Spine Wave, Inc. makes
Spine Wave, Inc. manufactures spinal fixation devices, including non-bioabsorbable bone screws, internal fixation rods, metallic and polymeric interbody fusion cages, reusable instrument trays, and spinal implant trials. Their portfolio also covers posterior cervical spine systems, spinal fixation plates, and anterior cervical plate systems designed for surgical spinal stabilization and fusion procedures.
The company’s devices are regulated under FDA classifications, including Class I and Class II, with submissions recorded in the FDA’s 510(k) and UDI registries.
Catalogue
Search and filter all 3,823 devicesShowing 1-50 of 3,823
Company details
- FDA FEI number
- 3004638600
- DUNS number
- 067789763
- Address
- THREE ENTERPRISE DR., SHELTON, CT, 06484
- GUDID@spinewave.com
- Phone
- 203-944-9494
FDA recalls
FDA recall records list 3 recalls initiated by Spine Wave, Inc., the earliest on 2010-10-22 and the most recent on 2015-05-04. By recorded status: 3 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 4 May 2015 Z-1960-2015 Class II Terminated Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm
2013
- 14 May 2013 Z-2187-2013 Class II Terminated A component Superior endplate manufactured from a different polymer than specified
2010
- 22 Oct 2010 Z-0967-2011 Unclassified (pre-2012) Terminated Package Insert Incorrect
Frequently asked questions
How many devices does Spine Wave, Inc. have in the registry?
The registry currently lists 3823 devices for Spine Wave, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spine Wave, Inc.'s devices?
Among its 50 most recently registered devices, Spine Wave, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Spine Wave, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Spine Wave, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Spine Wave, Inc.?
FDA recall records list 3 recalls initiated by Spine Wave, Inc., the most recent initiated on 4 May 2015. 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 Wave, Inc. in the registry?
The most recently registered devices listed for Spine Wave, Inc. include Proficient® Posterior Cervical Spine System 10-8546, Proficient® Posterior Cervical Spine System 10-8547, Proficient® Posterior Cervical Spine System 10-8530 and Proficient® Posterior Cervical Spine System 10-8529.