STRYKER CMF MEDPOR CUSTOMIZED IMPLANT


Device Classification Name

prosthesis, chin, internal

510(k) Number K121315
Device Name STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
Applicant
HOWMEDICA OSTEONICS CORP.
15 dart rd
newnan, 
GA 
30265

Applicant Contact stephanie fullard
Correspondent
HOWMEDICA OSTEONICS CORP.
15 dart rd
newnan, 
GA 
30265

Correspodent Contact stephanie fullard
Regulation Number 878.3550
Classification Product Code
FWP  
Date Received 05/02/2012
Decision Date 11/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No