FDA.reportPublic FDA data

SKELETAL DYNAMICS, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30067424813006742481SKELETAL DYNAMICS, INC1N2026-01-017300 N Kendall Drive Suite 800 Miami FL US 33156

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1233791336377974K254288Clavicle Fixation SystemHRS2026-03-23
1233792007592506K252949Geminus Volar Distal Radius Plating SystemHRS2025-11-13
1233791733800251K242436Proximal Humerus Fixation SystemHRS2024-11-14
1233791452851382K242055Freefix Forearm Plating SystemHRS2024-08-01
1233791938558248K241815Protean Fragment Plating SystemHRS2024-09-26
1233791318184781K240835Suture Button Repair SystemMBI2024-07-19
1233791031275154K233574Total Wrist Arthroplasty System (TWA)JWJ2024-07-03
1233791303800504K231623Distal Elbow Plating SystemHRS2023-08-28
1233791579666211K231447Double Internal Joint Stabilizer- ElbowOZI2023-12-15
1233791027542810K231188ALIGN Radial Head SystemKWI2023-09-28
1233791389913660K230908Hand Trauma Threaded Nail SystemHWC2023-04-28
1233791609466551K223318Internal Joint Stabilizer - ElbowOZI2023-05-10
1233791465600879K220723Hand Trauma Screw SystemHWC2022-05-12
1233791725058940K213895Distal Humerus Plating SystemHRS2022-01-13
1233791503018467K211439Small Bone Nailing SystemHTY2021-09-30
1233791354200976K201962Skeletal Dynamics Ulnar Shortening Plating SystemHRS2020-10-13
1233791253545672K201662REDUCT® Headless Compression Screw SystemHWC2020-07-16
1233791929257608K200701Skeletal Dynamics Midshaft Humerus Plating SystemHRS2020-05-14
1233791249858815K200538Skeletal Dynamics Forearm Plating SystemHRS2020-06-01
1233791749238536K200367Distal Humerus Plating SystemHRS2020-05-14
1233791063813377K182492Geminus Volar Distal Radius Plate SystemHRS2018-10-10
1233791729072554K180744Stablyx CMC Arthroplasty Implant SystemKYI2018-04-11
1233791872907042K172688Align Radial Head SystemKWI2017-12-22
1233791393580768K171590Distal Elbow Plating SystemHRS2017-06-27
1233791818132462K153208Internal Joint Stabilizer - ElbowOZI2015-12-31
1233792053333391K150675Dorsal Spanning PlateHRS2015-05-12
1233791654656994K143624Headless Compression Screw SystemHWC2015-01-13
1233791776865456K140892DISTAL ELBOW PLATING SYSTEMHRS2014-08-28
1233791228894589K140372FRAGMENT PLATE SYSTEMHRS2014-04-07
1233791866058183K122737GEMINUS FOSSA SPECIFIC PLATE SYSTEMHRS2012-10-03
1233791702293422K122310GEMINUS FOSSA SPECIFIC PLATE SYSTEMHRS2013-01-18
1233791225013551K111620SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICSHRS2011-08-23
1233792071988392K111068STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5KYI2011-12-30
1233791486248151K102103SKELETAL DYNAMICS STERILIZATION TRAYSKCT2010-12-07
1233792072440144K092721ALIGN RADIAL HEAD SYSTEMKWI2010-08-03
1233791772348223K092720WRIST ARTHRODESIS NAIL SYSTEMHSB2010-06-29
1233791020477570
1233791119656619
1233791140481678
1233791517738090
1233791584539044
1233791676991252

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS192026-03-23
HWC42023-04-28
OZI32023-12-15
KWI32023-09-28
KYI22018-04-11
MBI12024-07-19
JWJ12024-07-03
HTY12021-09-30
KCT12010-12-07
HSB12010-06-29