Skeletal Dynamics, LLC - FDA 510(k) Cleared Devices
Recent clearances: Geminus Volar Distal Radius Plate System, Stablyx CMC Arthroplasty Implant System
18
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Skeletal Dynamics, LLC Orthopedic ✕
17 devices
Cleared
Oct 10, 2018
Geminus Volar Distal Radius Plate System
Orthopedic
29d
Cleared
Apr 11, 2018
Stablyx CMC Arthroplasty Implant System
Orthopedic
20d
Cleared
Dec 22, 2017
Align Radial Head System
Orthopedic
107d
Cleared
Jun 27, 2017
Distal Elbow Plating System
Orthopedic
27d
Cleared
Dec 31, 2015
Internal Joint Stabilizer - Elbow
Orthopedic
56d
Cleared
May 12, 2015
Dorsal Spanning Plate
Orthopedic
57d
Cleared
Jan 13, 2015
Headless Compression Screw System
Orthopedic
22d
Cleared
Aug 28, 2014
DISTAL ELBOW PLATING SYSTEM
Orthopedic
142d
Cleared
Apr 07, 2014
FRAGMENT PLATE SYSTEM
Orthopedic
52d
Cleared
Jan 18, 2013
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
Orthopedic
170d
Cleared
Oct 03, 2012
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
Orthopedic
27d
Cleared
Dec 30, 2011
STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
Orthopedic
256d