REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)


Device Classification Name

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

510(k) Number K111061
Device Name REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)
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 04/18/2011
Decision Date 07/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Special
Reviewed by Third Party No

Combination Product

No