ENCORE SHOULDER REVISION GLENOID


Device Classification Name

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

510(k) Number K081448
Device Name ENCORE SHOULDER REVISION GLENOID
Applicant
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin, 
TX 
78758

Applicant Contact teffany hutto
Correspondent
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin, 
TX 
78758

Correspodent Contact teffany hutto
Regulation Number 888.3670
Classification Product Code
MBF  
Date Received 05/23/2008
Decision Date 09/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls