SPINE WAVE, INC.

FDA Device Registration & Listing · SHELTON, CT, US · Registration 3004638600

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004638600
FEI Number
3004638600
Entity Name
SPINE WAVE, INC.
City/State/Country
SHELTON, CT, US
Establishment Address
THREE ENTERPRISE DR., SUITE 210, SHELTON, CT 06484, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
SPINE WAVE, INC. (Owner Number: 9055730)
Owner / Operator Contact Address
THREE ENTERPRISE DR., SUITE 210, Shelton, CT 06484, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K181440
PMA Number
N/A

All Registered Proprietary Names

Annex® 2 Adjacent Level System SCREWDRIVER CAP DRIVER Salvo Spine System Leva(R) Spacer System Testa TP Pivoting Spacer System Spine Wave Navigated Instruments CapSure(R) PS System Funnels Leva(R) Anterior Expandable Spacer System Leva® Spacer System Salvo Spine System Leva(TM) Spacer System Spine Wave Navigated Instruments Exceed™ Biplanar Expandable Interbody System Sniper® Spine System SOUNDING PROBE PEDICLE PROBE Stronghold 3D Titanium Interbody Device System Salvo Spine System Sniper® Spine System TEMPLATE Sniper MIS System NERVE ROOT RETRACTOR True Position® Pivoting Spacer System FORCEPS PITUITARY RONGEUR Leva® Anterior Interbody System Leva® Spacer System CapSure(R) PS System CapSure(R) PS Spine System Sniper® Spine System StaXx® XD System Velocity™ Expandable Interbody System Salvo® Robotic Navigation Instruments BONE TAP RING CURETTE Salvo Spine System SPREADER DISTRACTOR Paramount™ Anterior Cervical Spine System OSTEOTOME StaXx(R) XD System Salvo Spine System BONE RASP AWL Salvo Spine System Ni-Lock® Anterior Cervical Plate System TAMP StaXx(R) XD System Proficient® Posterior Cervical Spine System Defender Anterior Cervical Plate System Abacus Spacer System Paramount® Anterior Cervical Spine System INSTRUMENT CASES TORQUE WRENCH Proficient Posterior Cervical Spine System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-12-09
HXX Screwdriver Orthopedic Class 1 888.4540 2007-06-25
KTZ Caliper Orthopedic Class 1 888.4150 2024-10-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-04-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-09-29
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-02-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-12-07
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-12-07
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2007-12-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-04-10
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-11-13
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2024-10-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-02-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2018-11-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-05-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-12-07
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-09-25
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-09-25
HXB Probe Orthopedic Class 1 888.4540 2007-06-25
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-07-23
HTO Reamer Orthopedic Class 1 888.4540 2024-10-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-11-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-11-13
HWT Template Orthopedic Class 1 888.4800 2004-07-01
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2010-07-16
GAD Retractor General, Plastic Surgery Class 1 878.4800 2006-07-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-03-03
HTD Forceps General, Plastic Surgery Class 1 878.4800 2007-09-13
HTX Rongeur Orthopedic Class 1 888.4540 2006-07-12
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2016-11-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-11-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-12-07
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-12-07
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2010-03-25
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2010-03-25
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-11-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-11-13
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2015-11-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-02-03
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-04-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-04-16
HWX Tap, Bone Orthopedic Class 1 888.4540 2007-06-25
HTF Curette General, Plastic Surgery Class 1 878.4800 2006-07-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-01-02
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2006-07-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-05-10
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-05-10
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-03-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-12-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-12-06
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2006-07-12
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2010-12-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-02-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-02-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-02-20
HTR Rasp General, Plastic Surgery Class 1 878.4800 2006-07-12
HWJ Awl Orthopedic Class 1 888.4540 2007-06-25
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-10-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-10-23
HXG Tamp Orthopedic Class 1 888.4540 2004-07-01
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-05-10
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2010-09-24
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2018-01-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-07-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-05-13
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2018-06-07
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-05-10
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-05-10
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2004-07-01
HXC Wrench Orthopedic Class 1 888.4540 2007-06-25
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2018-08-15

Official Correspondent

RONALD SMITH

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SPINE WAVE, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13
K140696 Pioneer Surgical Technology, Inc. STREAMLINE TL SPINAL FIXATION SYSTEM 2014-04-10
K141398 Medicrea International SA PASS LP SPINAL SYSTEM 2015-01-09
K160980 Spineology, Inc. Threshold Pedicular Fixation System, Palisade Pedicular Fixation System 2016-05-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004638600. Last updated year: 2026. Please use registration number 3004638600 when referencing this establishment in official correspondence.
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