SYNTHES RADIAL HEAD PROSTHESIS SYSTEM


Device Classification Name

prosthesis, elbow, hemi-, radial, polymer

510(k) Number K112030
Device Name SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
Applicant
SYNTHES USA, LLC
1301 goshen parkway
west chester, 
PA 
19380

Applicant Contact angela f lassandro
Correspondent
SYNTHES USA, LLC
1301 goshen parkway
west chester, 
PA 
19380

Correspodent Contact angela f lassandro
Regulation Number 888.3170
Classification Product Code
KWI  
Date Received 07/15/2011
Decision Date 06/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls