STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5


Device Classification Name

prosthesis, wrist, carpal trapezium

510(k) Number K111068
Device Name STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
Applicant
SKELETAL DYNAMICS, LLC
8905 sw 87 avenue, suite 201
miami, 
FL 
33176

Applicant Contact ana m escagedo, esq
Correspondent
SKELETAL DYNAMICS, LLC
8905 sw 87 avenue, suite 201
miami, 
FL 
33176

Correspodent Contact ana m escagedo, esq
Regulation Number 888.3770
Classification Product Code
KYI  
Date Received 04/18/2011
Decision Date 12/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No