ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38


Device Classification Name

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

510(k) Number K080402
Device Name ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38
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 888.3660
Classification Product Code
KWS  
Date Received 02/14/2008
Decision Date 03/28/2008
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