FDA Registration
Active
🇺🇸 United States
SPINE WAVE, INC.
Reg #: 3004638600
·
FEI: 3004638600
·
Expires 2026
Products
31
Proprietary Names
51
Establishment Types
3
Classifications
31
Registration Details
- Registration Name
- SPINE WAVE, INC.
- Registration Number
- 3004638600
- FEI Number
- 3004638600
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- THREE ENTERPRISE DR., SUITE 210
- City
- SHELTON
- State
- CT
- ZIP
- 06484
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251131
Owner / Operator
- Firm Name
- SPINE WAVE, INC.
- Operator Number
- 9055730
- Address
- THREE ENTERPRISE DR., SUITE 210
- City
- Shelton
- State
- CT
- Postal Code
- 06484
- Country
- US
- Correspondent
- RONALD K SMITH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-12-09 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2007-06-25 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2024-10-23 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2016-04-18 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2021-02-09 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2009-12-07 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2009-12-07 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2007-12-03 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2024-10-23 |
| Probe | HXB | Class 1 | Orthopedic | No | 2007-06-25 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2024-10-23 |
| Template | HWT | Class 1 | Orthopedic | No | 2004-07-01 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2006-07-12 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2007-09-13 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2006-07-12 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2016-11-28 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2015-11-13 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2007-06-25 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2006-07-12 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-07-12 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2017-03-02 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2006-07-12 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2006-07-12 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2007-06-25 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2015-10-23 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2004-07-01 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2018-01-02 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2004-07-01 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2007-06-25 |
| Bender | HXW | Class 1 | Orthopedic | No | 2007-06-25 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2021-12-03 |
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
Leva(TM) Spacer System
Exceed Biplanar Expandable Interbody System
Sniper® Spine System
SOUNDING PROBE
PEDICLE PROBE
Stronghold 3D Titanium Interbody Device System
TEMPLATE
Sniper MIS System
NERVE ROOT RETRACTOR
True Position® Pivoting Spacer System
FORCEPS
PITUITARY RONGEUR
Leva® Anterior Interbody System
CapSure(R) PS Spine System
StaXx® XD System
Velocity Expandable Interbody System
Salvo® Robotic Navigation Instruments
BONE TAP
RING CURETTE
SPREADER
DISTRACTOR
Paramount Anterior Cervical Spine System
OSTEOTOME
StaXx(R) XD System
BONE RASP
AWL
Ni-Lock® Anterior Cervical Plate System
TAMP
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
Proficient Posterior Cervical Spine System
CAPSURE PS SPINE SYSTEM
ROD BENDER
Stronghold® C 3D Titanium Interbody Device System
Accent® Cervical Spacer System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Repack or Relabel Medical Device