Spine Wave, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Dynamo™ Spinal Cement, Exceed® Biplanar Expandable Interbody System, Testa TP Pivoting Spacer System
59
Total
59
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spine Wave, Inc. Orthopedic ✕
59 devices
Cleared
Jun 15, 2026
Dynamo™ Spinal Cement
Orthopedic
137d
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
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