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Seaspine, Inc.

Also registered as Seaspine, Seaspine Corporation

United StatesFDA applicant, unverified

Devices
1,353
FDA recalls
11

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

Newest first, rows 1,301-1,350 of 1,353

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  • Malibu 12-5545

    Withdrawn Registry: GUDID Class:II

  • Malibu 15-5550

    Withdrawn Registry: GUDID Class:II

  • Malibu 18-8030

    Withdrawn Registry: GUDID Class:II

  • Malibu 15-6055

    Withdrawn Registry: GUDID Class:II

  • Ucr 11-6755

    Withdrawn Registry: GUDID Class:II

  • Ucr 11-6035

    Withdrawn Registry: GUDID Class:II

  • Ucr 10-6055

    Withdrawn Registry: GUDID Class:II

  • Malibu™ AOSSIMP

    Withdrawn Registry: GUDID Class:II

  • Ucr 10-8030

    Withdrawn Registry: GUDID Class:II

  • Ucr 11-8040

    Withdrawn Registry: GUDID Class:II

  • Ucr 11-8060

    Withdrawn Registry: GUDID Class:II

  • Ucr 10-8055

    Withdrawn Registry: GUDID Class:II

  • Ucr 10-6050

    Withdrawn Registry: GUDID Class:II

  • Ucr 11-6050

    Withdrawn Registry: GUDID Class:II

  • Ucr Ucrimp

    Withdrawn Registry: GUDID Class:II

  • Ucr 10-5530

    Withdrawn Registry: GUDID Class:II

  • Malibu™ MLBMIMP

    Withdrawn Registry: GUDID Class:II

  • Ucr 10-4750

    Withdrawn Registry: GUDID Class:II

  • Ucr 10-4755

    Withdrawn Registry: GUDID Class:II

  • Ucr 10-5550

    Withdrawn Registry: GUDID Class:II

  • Sierra Ref K062934

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ucr Spinal System Ref K032739

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cardiff Anterior Cervical Plate System Ref K083338

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hollywood, Pacifica, Redondo, Ventura Ref K082310

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zuma, Model 55-Xxxx/56-Xxxx Ref K082926

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Newport Spinal System Ref K083089

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Anterior Lumbar Buttress System Ref K040130

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sierra System Ref K080526

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Malibu Spinal System Ref K051663

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Seaspine Vbr System Ref K052170

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sierra Ref K072729

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zuma-C Ref K092521

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ucr Spinal System Ref K043232

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ucr Spinal System, Laminar Hooks, Pedicle Hooks, And Instruments Ref K031381

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Integra Expandable Interverebral Body Fusion Device (Ibd) System Ref K133418

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cambria Ref K082309

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Integra Laminoplasty System Ref K150469

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cardiff Anterior Cervical Plate System Ref K112206

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • NorthStar OCT System Ref K231654

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Malibu Spinal System Ref K061342

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Seaspine Monopolar Probe Sysyem Ref K111671

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Zuma Ref K071726

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sonoma Anterior Cervical Plate System Ref K032368

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Malibu Spinal System Ref K072605

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Seaspine Spacer System Ref K102026

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Integra Laminoplasty System Ref K130830

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Integra Facet Fixation System Ref K132859

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Malibu Spinal System With The Daytona Deformity System Ref K122571

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Integra Interspinous Process System Ref K121924

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Redondo-L Ref K103297

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1,301-1,350 of 1,353

Showing 1,301-1,350 of 1,353

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