METS MODULAR PROXIMAL FEMUR


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, cemented

510(k) Number K121056
Device Name METS MODULAR PROXIMAL FEMUR
Applicant
STANMORE IMPLANTS WORLDWIDE LTD.
690 canton street
suite 302
westwood, 
MA 
02090

Applicant Contact nancy c macdonald
Correspondent
STANMORE IMPLANTS WORLDWIDE LTD.
690 canton street
suite 302
westwood, 
MA 
02090

Correspodent Contact nancy c macdonald
Regulation Number 888.3350
Classification Product Code
JDI  
Date Received 04/06/2012
Decision Date 09/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No