Seaspine, Inc.

Also registered as Seaspine, Seaspine Corporation

United StatesFDA applicant, unverified

Devices: 1,353
FDA recalls: 11

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Seaspine, Inc. makes

Seaspine, Inc. manufactures spinal fixation and fusion systems, including anterior cervical plates, expandable intervertebral body fusion devices, and expandable spinal implants for both cervical and lumbar regions. Their portfolio includes modular plate systems, expandable cages, and specialized spinal implants designed for surgical stabilization and fusion procedures.

The company’s devices are classified as Class II and Unclassified (U) under FDA regulations, with most products cleared via the 510(k) pathway. These products are listed in the FDA’s 510(k) registry, and the company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1,353

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Company details

DUNS number: 119614407

FDA recalls11

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 11 recalls initiated by Seaspine, Inc., the earliest on 2009-03-04 and the most recent on 2014-05-21. By recorded status: 11 terminated. The reasons filed fall into these groups: 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.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 11 recalls.

2014
- 21 May 2014 Z-1841-2014 Class II Terminated Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to twist or become rounded during use. Distribution: US Distribution including the states of : AL, CA, OH, NM and TN. Submission number: K043232
2009
- 4 Mar 2009 Z-1918-2009 Unclassified (pre-2012) Terminated SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. Distribution: Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and…
  Full distribution text
  Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.
  Submission number: K051942
- 4 Mar 2009 Z-1919-2009 Unclassified (pre-2012) Terminated SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. Distribution: Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and…
  Full distribution text
  Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.
  Submission number: K051942
- 4 Mar 2009 Z-1920-2009 Unclassified (pre-2012) Terminated SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. Distribution: Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and…
  Full distribution text
  Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.
  Submission number: K051942
- 4 Mar 2009 Z-1921-2009 Unclassified (pre-2012) Terminated SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. Distribution: Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and…
  Full distribution text
  Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.
  Submission number: K051942
- 4 Mar 2009 Z-1922-2009 Unclassified (pre-2012) Terminated SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. Distribution: Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and…
  Full distribution text
  Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.
  Submission number: K051942
- 4 Mar 2009 Z-1923-2009 Unclassified (pre-2012) Terminated SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. Distribution: Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and…
  Full distribution text
  Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.
  Submission number: K051942
- 4 Mar 2009 Z-1924-2009 Unclassified (pre-2012) Terminated SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. Distribution: Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and…
  Full distribution text
  Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.
  Submission number: K051942
- 4 Mar 2009 Z-1925-2009 Unclassified (pre-2012) Terminated SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. Distribution: Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and…
  Full distribution text
  Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.
  Submission number: K051942
- 4 Mar 2009 Z-1926-2009 Unclassified (pre-2012) Terminated SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. Distribution: Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and…
  Full distribution text
  Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.
  Submission number: K051942

Show all 11 recalls

2009
- 4 Mar 2009 Z-1927-2009 Unclassified (pre-2012) Terminated SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. Distribution: Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and…
  Full distribution text
  Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.
  Submission number: K051942

Frequently asked questions

How many devices does Seaspine, Inc. have in the registry?

The registry currently lists 1353 devices for Seaspine, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Seaspine, Inc.'s devices?

Among its 50 most recently registered devices, Seaspine, Inc. has devices listed in FDA GUDID (50 devices).

What risk classes do Seaspine, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Seaspine, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Seaspine, Inc.?

FDA recall records list 11 recalls initiated by Seaspine, Inc., the most recent initiated on 21 May 2014. 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 Seaspine, Inc. in the registry?

The most recently registered devices listed for Seaspine, Inc. include Newport 60-6040, Malibu 16-4525, Malibu 69-7025 and Malibu 13-8080.

Generated automatically from registry data and not verified by a human reviewer.