510(k) Report

FDA applicant

SeaSpine Orthopedics Corporation

Carlsbad, CA67 decisions2016–202612 recalls

FDA records 67 decisions for SeaSpine Orthopedics Corporation (Carlsbad, CA) from 2016 to 2026: 67 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 86 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 253 predicates, 110 of them its own earlier devices. 12 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided SeaSpine Orthopedics Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2016: 52017: 72018: 82019: 62020: 142021: 92022: 52023: 52024: 52025: 22026 (partial year): 1
2016high 14 (2020) · low 2 (2025)2026

2026 so far, outlined.

Recalls per year

3in 2026

2024: 62025: 32026 (partial year): 3
2016high 6 (2024) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — SeaSpine Orthopedics Corporation by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like SeaSpine Orthopedics Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar20decisions
  • NKBThoracolumbosacral Pedicle Screw System14decisions
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical8decisions
  • MQVFiller, Bone Void, Calcium Compound7decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body5decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical4decisions

Also: OLO (3), OVD (2), PGM (1), NKG (1), PEK (1), OWI (1).

How long do its 510(k) reviews take?

Since 2016, its 66 510(k)s took a median of 86 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 93 days; 38 of its 66 were faster than that.

Whose devices does it build on?

Its devices cite 253 predicates; 110 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 170 times; 110 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene…SeaSpine Orthopedics Corporation · 20216cite it
  • K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation · 20166cite it
  • K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System…SeaSpine Orthopedics Corporation · 20176cite it
  • K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation · 20196cite it
  • K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation · 20206cite it
  • K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation · 20216cite it

What has FDA decided for it lately?

  • K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody…SeaSpine Orthopedics Corporation · 2026
  • K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation · 20251 recall
  • K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation · 2025
  • K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation · 20242 recalls
  • K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody…SeaSpine Orthopedics Corporation · 2024
  • K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation · 2024
  • K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw…SeaSpine Orthopedics Corporation · 20242 recalls
  • K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024

All 67 as SeaSpine Orthopedics Corporation →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K211606SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm…Aug 19, 2026Class II
  • K172130OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm…Jul 2, 2026Class II
  • K173882SeaSpine Polyaxial Head REF Number: 41-3010May 28, 2026Class II
  • K172517Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation…Nov 17, 2025Class II
  • K250908Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The…Sep 19, 2025Class II
  • K192132Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody SystemAug 6, 2025Class II

Other applicant names beginning “SeaSpine”

FDA records each applicant name separately; these may or may not be the same firm.

Seaspine, Inc. 33