HUMELOCK CEMENTED SHOULDER PROSTHESIS


Device Classification Name

prosthesis, shoulder, hemi-, humeral, metallic uncemented

510(k) Number K111097
Device Name HUMELOCK CEMENTED SHOULDER PROSTHESIS
Applicant
FX SOLUTIONS
1663 rue de majornas
viriat, 

FR

01440

Applicant Contact cheryl hastings
Correspondent
FX SOLUTIONS
1663 rue de majornas
viriat, 

FR

01440

Correspodent Contact cheryl hastings
Regulation Number 888.3690
Classification Product Code
HSD  
Date Received 04/20/2011
Decision Date 11/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No