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Skeletal Dynamics, Inc.

USA · Miami

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Singapore, Australia, Hong Kong, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

17listed device types

Class I 5Class II 12Class III 0

plus 44 registration records and 40 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

7active ARTG entries

Class I 1IIa 3IIb 3

HKHong KongMDACS

10valid listings

Class III 10

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States44 registration records, 40 510(k), 0 PMA, 3 excluded

Brazil0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: SKELETAL DYNAMICS, INC · SKELETAL DYNAMICS STRATEGIC MANUFACTURING CENTER

Same-named companies — This database also contains companies with near-identical names: SKELETAL DYNAMICS STRATEGIC MANUFACTURING CENTER. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

42010

32011

12012

12013

22014

32015

22017

22018

52020

12021

22022

52023

62024

12025

22026

FDA listed device types

showing 8 of 17

Internal Hinged Elbow Fixator 1Rod, Fixation, Intramedullary And Accessories 1Instruments Designed For Press-Fit Osteochondral Implants 1Prosthesis, Elbow, Hemi-, Radial, Polymer 1Pin, Fixation, Smooth 1Prosthesis, Wrist, Carpal Trapezium 1Plate, Fixation, Bone 1Screw, Fixation, Bone 1

Market	Identifier	Name	Class / date
US	K261770	Suture Button Repair System	2026-07-29
US	K254288	Clavicle Fixation System	2026-03-23
US	K252949	Geminus Volar Distal Radius Plating System	2025-11-13

Skeletal Dynamics, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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