# SeaSpine Orthopedics Corporation

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 67 (2016–2026): 67 510(k) clearances
- Product codes: MAX (20), NKB (14), OVE (8), MQV (7), KWQ (5), ODP (4), OLO (3), OVD (2), PGM (1), NKG (1), PEK (1), OWI (1)
- 510(k) review time since 2016: median 86 days, against 93 for FDA's reviews in the same codes and years (38 of 66 faster)
- Predicates its devices cite: 253 (110 its own); citations of its devices by later devices: 170 (110 its own)
- Recalls linked to its devices: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Seaspine, Inc.: 61 (https://510kreport.com/company/seaspine)
- Theken Spine, LLC: 15 (https://510kreport.com/company/theken-spine)
- Globus Medical, Inc.: 7 (https://510kreport.com/company/globus-medical)
- Nu Vasive, Incorporated: 7 (https://510kreport.com/company/nu-vasive)
- Medtronic Sofamor Danek USA, Inc.: 6 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Medtronic Sofamor Danek: 4 (https://510kreport.com/company/medtronic-sofamor-danek)
- Theken Surgical,Llc: 4 (https://510kreport.com/company/theken-surgical)
- Camber Spine Technologies: 3 (https://510kreport.com/company/camber-spine-technologies)

## Firms that cite its devices most
- Vy Spine, LLC: 7 (https://510kreport.com/company/vy-spine)
- Orthofix Medical, Inc.: 7 (https://510kreport.com/company/orthofix-medical)
- Spineart: 6 (https://510kreport.com/company/spineart)
- S.M.A.I.O: 4 (https://510kreport.com/company/smaio)
- NanoHive Medical, LLC: 4 (https://510kreport.com/company/nanohive-medical)
- Alphatec Spine, Inc.: 3 (https://510kreport.com/company/alphatec-spine)
- Carlsmed, Inc.: 2 (https://510kreport.com/company/carlsmed)
- SI-BONE, Inc.: 2 (https://510kreport.com/company/si-bone)

## Its most-cited devices
- K210497: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System (2021), cited by 6
- K161081: SeaSpine Shoreline ACS - Anterior Cervical Standalone System (2016), cited by 6
- K173260: SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System (2017), cited by 6
- K183083: Shoreline Cervical Interbody RT System (2019), cited by 6
- K200879: SeaSpine Meridian System, SeaSpine Regatta Lateral System (2020), cited by 6
- K212904: SeaSpine WaveForm C Interbody System (2021), cited by 6

## Recent decisions
- K253420: Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy (Jul 1, 2026)
- K250908: Virata Spinal Fixation System (Jun 18, 2025)
- K243659: FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (Apr 2, 2025)
- K242273: Cove Putty, OsteoCove Putty (Sep 25, 2024)
- K241466: Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System (Jun 20, 2024)
- K240566: Reef L Interbody System; WaveForm L Interbody System (Apr 26, 2024)
- K232566: NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System (Apr 19, 2024)
- K233694: Meridian Interbody System; WaveForm A Interbody System (Jan 12, 2024)

Source page: https://510kreport.com/company/seaspine-orthopedics