Spine Wave, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Spine Wave, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Exceed® Biplanar Expandable Interbody System, Testa TP Pivoting Spacer System, Annex® 2 Adjacent Level System
58
Total
58
Cleared
0
Denied
Spine Wave, Inc. has 58 FDA 510(k) cleared orthopedic devices. Based in Shelton, US.
Latest FDA clearance: May 2026. 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.
FDA 510(k) Regulatory Record - Spine Wave, Inc.
58 devices
Cleared
May 29, 2026
Exceed® Biplanar Expandable Interbody System
Orthopedic
51d
Cleared
Jun 27, 2025
Testa TP Pivoting Spacer System
Orthopedic
197d
Cleared
Jun 06, 2025
Annex® 2 Adjacent Level System
Orthopedic
56d
Cleared
Apr 03, 2025
Salvo® Robotic Navigation Instruments
Orthopedic
141d
Cleared
May 06, 2024
Salvo® Spine System
Orthopedic
55d
Cleared
Jul 25, 2023
Exceed™ Biplanar Expandable Interbody System
Orthopedic
84d
Cleared
Aug 29, 2022
Salvo® Spine System
Orthopedic
25d
Cleared
Nov 05, 2020
Salvo® Spine System
Orthopedic
69d
Cleared
Oct 10, 2019
Spine Wave Navigated Instruments
Orthopedic
27d
Cleared
Jul 10, 2019
Salvo™ Spine System
Orthopedic
82d
Cleared
Dec 12, 2018
Salvo™ Spine System
Orthopedic
49d
Cleared
Oct 24, 2018
Spine Wave Navigated Instruments
Orthopedic
128d
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