GMK REVISION HYBRID LINERS


Device Classification Name

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer

510(k) Number K111283
Device Name GMK REVISION HYBRID LINERS
Applicant
MEDACTA INTERNATIONAL
4725 calle quetzal, unit b
camarillo, 
CA 
93012

Applicant Contact adam gross
Correspondent
MEDACTA INTERNATIONAL
4725 calle quetzal, unit b
camarillo, 
CA 
93012

Correspodent Contact adam gross
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 05/06/2011
Decision Date 05/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No