# Seaspine, Inc.

- Location (FDA's records): Vista, CA
- FDA decisions: 33 (2003–2023): 33 510(k) clearances
- Names in FDA's records: Seaspine, Inc. (27); Seaspine (5); Seaspine Corporation (1)
- Product codes: NKB (6), MAX (5), KWQ (4), KWP (3), MNI (3), NQW (2), MQP (2), ODP (1), OVE (1), MRW (1), ETN (1), NKG (1)
- Predicates its devices cite: 117 (36 its own); citations of its devices by later devices: 125 (36 its own)
- Recalls linked to its devices: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Sofamor Danek: 13 (https://510kreport.com/company/medtronic-sofamor-danek)
- Interpore Cross Intl.: 12 (https://510kreport.com/company/interpore-cross-intl)
- Depuyacromed: 12 (https://510kreport.com/company/depuyacromed)
- Synthes (Usa): 6 (https://510kreport.com/company/synthes-usa)
- Iame, Inc.: 6 (https://510kreport.com/company/iame)
- International Advanced Medical Enterprises, Inc.: 5 (https://510kreport.com/company/international-advanced-medical-enterprises)
- Synthes Spine: 3 (https://510kreport.com/company/synthes-spine)
- Nuvasive, Inc.: 3 (https://510kreport.com/company/nuvasive)

## Firms that cite its devices most
- SeaSpine Orthopedics Corporation: 61 (https://510kreport.com/company/seaspine-orthopedics)
- Synthes (USA) Products, LLC: 3 (https://510kreport.com/company/synthes-usa-products)
- Vy Spine, LLC: 1 (https://510kreport.com/company/vy-spine)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)
- Theken Spine, LLC: 1 (https://510kreport.com/company/theken-spine)
- Spinal USA: 1 (https://510kreport.com/company/spinal-usa)
- Nuvasive, Inc.: 1 (https://510kreport.com/company/nuvasive)
- Reliance Medical Systems, LLC: 1 (https://510kreport.com/company/reliance-medical-systems)

## Its most-cited devices
- K082310: Hollywood, Pacifica, Redondo, Ventura (2008), cited by 18
- K142488: SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene (2014), cited by 10
- K051942: Malibu Spinal System (2005), cited by 9
- K061342: Malibu Spinal System (2006), cited by 9
- K051663: Malibu Spinal System (2005), cited by 9
- K072605: Malibu Spinal System (2007), cited by 7

## Recent decisions
- K231654: NorthStar OCT System (Aug 3, 2023)
- K212135: Dry DBM- A Putty (Oct 4, 2021)
- K150469: Integra Laminoplasty System (Mar 23, 2015)
- K142488: SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene (Dec 18, 2014)
- K133418: Integra Expandable Interverebral Body Fusion Device (Ibd) System (May 1, 2014)
- K132859: Integra Facet Fixation System (Nov 18, 2013)
- K121924: Integra Interspinous Process System (Sep 4, 2013)
- K130830: Integra Laminoplasty System (May 9, 2013)

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