Medical Device Manufacturer · US , Shelton , CT

Skeletal Dynamics, LLC - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 2010

Recent clearances: Geminus Volar Distal Radius Plate System, Stablyx CMC Arthroplasty Implant System

18
Total
18
Cleared
0
Denied

Skeletal Dynamics, LLC has 18 FDA 510(k) cleared orthopedic devices. Based in Shelton, US.

Historical record: 18 cleared submissions from 2010 to 2018.

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 - Skeletal Dynamics, LLC

18 devices
1-18 of 18
Cleared Oct 10, 2018
Geminus Volar Distal Radius Plate System
K182492 · HRS
Orthopedic · 29d
Cleared Apr 11, 2018
Stablyx CMC Arthroplasty Implant System
K180744 · KYI
Orthopedic · 20d
Cleared Dec 22, 2017
Align Radial Head System
K172688 · KWI
Orthopedic · 107d
Cleared Jun 27, 2017
Distal Elbow Plating System
K171590 · HRS
Orthopedic · 27d
Cleared Dec 31, 2015
Internal Joint Stabilizer - Elbow
K153208 · OZI
Orthopedic · 56d
Cleared May 12, 2015
Dorsal Spanning Plate
K150675 · HRS
Orthopedic · 57d
Cleared Jan 13, 2015
Headless Compression Screw System
K143624 · HWC
Orthopedic · 22d
Cleared Aug 28, 2014
DISTAL ELBOW PLATING SYSTEM
K140892 · HRS
Orthopedic · 142d
Cleared Apr 07, 2014
FRAGMENT PLATE SYSTEM
K140372 · HRS
Orthopedic · 52d
Cleared Jan 18, 2013
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
K122310 · HRS
Orthopedic · 170d
Cleared Oct 03, 2012
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
K122737 · HRS
Orthopedic · 27d
Cleared Dec 30, 2011
STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
K111068 · KYI
Orthopedic · 256d
Cleared Dec 13, 2011
HEADLESS COMPRESSION SCREW
K112672 · HWC
Orthopedic · 90d
Cleared Aug 23, 2011
SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE...
K111620 · HRS
Orthopedic · 74d
Cleared Dec 07, 2010
SKELETAL DYNAMICS STERILIZATION TRAYS
K102103 · KCT
General Hospital · 133d
Cleared Oct 04, 2010
AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM
K092723 · HRX
Orthopedic · 395d
Cleared Aug 03, 2010
ALIGN RADIAL HEAD SYSTEM
K092721 · KWI
Orthopedic · 333d
Cleared Jun 29, 2010
WRIST ARTHRODESIS NAIL SYSTEM
K092720 · HSB
Orthopedic · 298d
Filters