Medical Device Manufacturer · US , Shelton , CT

Spine Wave, Inc. - FDA 510(k) Cleared Devices

57 submissions · 57 cleared · Since 2004
57
Total
57
Cleared
0
Denied

Spine Wave, Inc. has 57 FDA 510(k) cleared orthopedic devices. Based in Shelton, US.

Latest FDA clearance: Jun 2025. Active since 2004.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

57 devices
1–12 of 57
Testa TP Pivoting Spacer System
K243816 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar · Orthopedic
Jun 2025 197d
Annex? 2 Adjacent Level System
K251131 · NKB Thoracolumbosacral Pedicle Screw System · Orthopedic
Jun 2025 56d
Salvo? Robotic Navigation Instruments
K243514 · OLO Orthopedic Stereotaxic Instrument · Orthopedic
Apr 2025 141d
Salvo? Spine System
K240685 · NKB Thoracolumbosacral Pedicle Screw System · Orthopedic
May 2024 55d
Exceed? Biplanar Expandable Interbody System
K231275 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar · Orthopedic
Jul 2023 84d
Salvo? Spine System
K222362 · NKB Thoracolumbosacral Pedicle Screw System · Orthopedic
Aug 2022 25d
Salvo? Spine System
K202476 · NKB Thoracolumbosacral Pedicle Screw System · Orthopedic
Nov 2020 69d
Spine Wave Navigated Instruments
K192526 · OLO Orthopedic Stereotaxic Instrument · Orthopedic
Oct 2019 27d
Salvo? Spine System
K191045 · NKB Thoracolumbosacral Pedicle Screw System · Orthopedic
Jul 2019 82d
Salvo? Spine System
K182954 · NKB Thoracolumbosacral Pedicle Screw System · Orthopedic
Dec 2018 49d
Spine Wave Navigated Instruments
K181596 · OLO Orthopedic Stereotaxic Instrument · Orthopedic
Oct 2018 128d
Proficient? Posterior Cervical Spine System
K181440 · NKG Posterior Cervical Screw System · Orthopedic
Jul 2018 59d

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