HEADLESS COMPRESSION SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K112672
Device Name HEADLESS COMPRESSION SCREW
Applicant
SKELETAL DYNAMICS, LLC
8905 sw 87 avenue, suite 201
miami, 
FL 
33176

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

Correspodent Contact ana m escagedo
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 09/14/2011
Decision Date 12/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No