RSP GLENOID BASEPLATE POROUS COATED


Device Classification Name

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

510(k) Number K112069
Device Name RSP GLENOID BASEPLATE POROUS COATED
Applicant
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin, 
TX 
78758

Applicant Contact william garzon
Correspondent
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin, 
TX 
78758

Correspodent Contact william garzon
Regulation Number 888.3660
Classification Product Code
KWS  
Date Received 07/20/2011
Decision Date 11/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No