SeaSpine Orthopedics Corporation - FDA 510(k) Cleared Devices
Recent clearances: Virata Spinal Fixation System, FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments, Cove Putty, OsteoCove Putty
66
Total
66
Cleared
0
Denied
FDA 510(k) Regulatory Record - SeaSpine Orthopedics Corporation Orthopedic ✕
66 devices
Cleared
Jun 18, 2025
Virata Spinal Fixation System
Orthopedic
84d
Cleared
Apr 02, 2025
FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
Orthopedic
126d
Cleared
Sep 25, 2024
Cove Putty, OsteoCove Putty
Orthopedic
55d
Cleared
Jun 20, 2024
Shoreline ACS Interbody System
Orthopedic
28d
Cleared
Apr 26, 2024
Reef L Interbody System
Orthopedic
57d
Cleared
Apr 19, 2024
NewPort Spinal System
Orthopedic
239d
Cleared
Jan 12, 2024
Meridian Interbody System
Orthopedic
56d
Cleared
Nov 28, 2023
Shoreline ACS Interbody System
Orthopedic
49d
Cleared
Sep 27, 2023
Cove Strip, OsteoCove Strip
Orthopedic
26d
Cleared
Sep 14, 2023
Cove Putty, OsteoCove Putty
Orthopedic
156d
Cleared
Aug 21, 2023
Cove Strip
Orthopedic
179d
Cleared
Feb 03, 2023
Manta Ray TDF Spacer
Orthopedic
366d
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