SeaSpine Orthopedics Corporation
Carlsbad, CA, US
SEASPINE ORTHOPEDICS CORPORATION appears in FDA device records in Carlsbad, CA. FDA records list 67 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 67FDA records hold 67 510(k) clearances for SeaSpine Orthopedics Corporation between 2016 and 2026. The busiest year on record is 2020, with 14. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 5 |
| 2017 | 7 |
| 2018 | 8 |
| 2019 | 6 |
| 2020 | 14 |
| 2021 | 9 |
| 2022 | 5 |
| 2023 | 5 |
| 2024 | 5 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | MAX | Substantially Equivalent | |
| K250908 | Virata Spinal Fixation System | NKB | Substantially Equivalent | |
| K243659 | FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | OLO | Substantially Equivalent | |
| K242273 | Cove Putty, OsteoCove Putty | MQV | Substantially Equivalent | |
| 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 | MAX | Substantially Equivalent | |
| K240566 | Reef L Interbody System; WaveForm L Interbody System | MAX | Substantially Equivalent | |
| 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 | NKB | Substantially Equivalent | |
| K233694 | Meridian Interbody System; WaveForm A Interbody System | MAX | Substantially Equivalent | |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | OVE | Substantially Equivalent | |
| K232668 | Cove Strip, OsteoCove Strip | MQV | Substantially Equivalent | |
| K231030 | Cove Putty, OsteoCove Putty | MQV | Substantially Equivalent | |
| K230486 | Cove Strip | MQV | Substantially Equivalent | |
| K220296 | Manta Ray TDF Spacer | ODP | Substantially Equivalent | |
| K222753 | SeaSpine 7D Navigation Instruments | OLO | Substantially Equivalent | |
| K222732 | WaveForm A Interbody System | MAX | Substantially Equivalent | |
| K222110 | Mariner RDX System | NKB | Substantially Equivalent | |
| K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | MAX | Substantially Equivalent | |
| K213420 | WaveForm L System, WaveForm TO System, WaveForm TA System | MAX | Substantially Equivalent | |
| K212904 | SeaSpine WaveForm C Interbody System | OVE | Substantially Equivalent | |
| K213359 | SeaSpine WaveForm, C Interbody System | OVE | Substantially Equivalent | |
| K212692 | Mariner Pedicle Screw System | NKB | Substantially Equivalent | |
| K212540 | Explorer TO System | MAX | Substantially Equivalent | |
| K212139 | Admiral ACP System | KWQ | Substantially Equivalent | |
| K211903 | Shoreline Threaded TruProfile® Plate | KWQ | Substantially Equivalent | |
| 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 | MAX | Substantially Equivalent | |
| K211606 | Mariner Deformity System | NKB | Substantially Equivalent | |
| K210583 | SeaSpine WaveForm™ A Interbody System | MAX | Substantially Equivalent | |
| K201755 | WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System | MAX | Substantially Equivalent | |
| K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System | MAX | Substantially Equivalent | |
| K201073 | Seaspine WaveForm C Interbody System | OVE | Substantially Equivalent | |
| K201646 | Shoreline ACS (Anterior Cervical System) | OVE | Substantially Equivalent | |
| K202064 | Admiral ACP System | KWQ | Substantially Equivalent | |
| K201240 | Mariner Cap System | OWI | Substantially Equivalent | |
| K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System | MAX | Substantially Equivalent | |
| K200885 | Meridian Anterior Plate System, Regatta Lateral Plate System | KWQ | Substantially Equivalent | |
| K200290 | Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) | MQV | Substantially Equivalent | |
| K193636 | SeaSpine Reef TH System | MAX | Substantially Equivalent | |
| K193615 | NorthStar™ OCT Spinal System | NKG | Substantially Equivalent | |
| K193418 | SeaSpine Skipjack System | MAX | Substantially Equivalent | |
| K200381 | Daytona® Small Stature Spinal System | NKB | Substantially Equivalent | |
| K193224 | Daytona® Small Stature Growth Rod Conversion Set | PGM | Substantially Equivalent | |
| K192132 | SeaSpine Beachside System | MAX | Substantially Equivalent | |
| K193040 | Resorbable Mesh Device | MQV | Substantially Equivalent | |
| K191648 | Mariner MIS Pedicle Screw System; SeaSpine Navigation System | NKB | Substantially Equivalent | |
| K183639 | Mariner Outrigger Revision System | NKB | Substantially Equivalent | |
| K190655 | SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System | OVE | Substantially Equivalent | |
| K183083 | Shoreline Cervical Interbody RT System | ODP | Substantially Equivalent | |
| K181079 | SeaSpine Regatta Lateral System | MAX | Substantially Equivalent | |
| K180686 | SeaSpine Daytona Small Stature Spinal System | NKB | Substantially Equivalent | |
| K172517 | SeaSpine Navigation System | OLO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012120772 | 3012120772 | SEASPINE ORTHOPEDICS CORPORATION | 5770 Armada Dr, Carlsbad, CA 92008 US | 2026 | and 41 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HXWBender
- HTWBit, Drill
- OWIBone Fixation Cerclage, Sublaminar
- HXYBrace, Drill
- HTFCurette
- FZSCurette, Surgical, General Use
- FZTCutter, Surgical
- HXZCutter, Wire
- HWBExtractor
- MQVFiller, Bone Void, Calcium Compound
- HTDForceps
- HXEFork
- HTJGauge, Depth
- PGMGrowing Rod System
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- GDGHook, Surgical, General & Plastic Surgery
- HWAImpactor
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- OJHOrthopedic Tray
- MNIOrthosis, Spinal Pedicle Fixation
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- GFIOsteotome, Manual
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- NKGPosterior Cervical Screw System
- HXBProbe
- HTRRasp
- GADRetractor
- HTXRongeur
- HXXScrewdriver
- MQPSpinal Vertebral Body Replacement Device
- PEKSpinous Process Plate
- HWDStarter, Bone Screw
- MRWSystem, Facet Screw Spinal Device
- HXGTamp
- HWXTap, Bone
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- HXSTwister, Wire
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2762-2026 | SeaSpine Polyaxial Head REF Number: 41-3010 | Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. | Class II | Open, Classified | |
| Z-0937-2026 | Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-400145; Navigation, 5.5mm Drill, REF: PC2-400155; Navigation, 3.5mm Tap, REF: PC2-400235; Navigation, 4.0mm Tap, REF: PC2-400240; Navigation, 4.5mm Tap, REF: PC2-400245; Navigation, 4.5mm Dual Lead Tap, REF: PC2-400345; Navigation, 5.5mm Dual Lead Tap, REF: PC2-400355 | The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only. | Class II | Open, Classified | |
| Z-2554-2025 | Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System | Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking. | Class II | Open, Classified | |
| Z-0752-2025 | Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. | Class II | Open, Classified | |
| Z-0751-2025 | Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. | Class II | Open, Classified | |
| Z-2357-2024 | Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No | Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces. | Class II | Open, Classified | |
| Z-2235-2024 | Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure | Class II | Open, Classified | |
| Z-2234-2024 | Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure | Class II | Open, Classified | |
| Z-1620-2024 | Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems. | Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface. | Class II | Open, Classified | |
| Z-1605-2024 | Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050; Mariner RDX Trauma Head, REF: MX1-000060; Mariner RDX Extended Trauma Head. REF: MX1-000070, part of Mariner RDX Alpha Instruments and Implants, REF: AMRDX and Mariner RDX TD Alpha Implants, REF: AMRDXTD, which are pedicle screw systems. | Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain