SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM


Device Classification Name

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

510(k) Number K081016
Device Name SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
Applicant
SMITH & NEPHEW, INC.
1450 e brooks road
memphis, 
TN 
38116

Applicant Contact jason sells
Correspondent
SMITH & NEPHEW, INC.
1450 e brooks road
memphis, 
TN 
38116

Correspodent Contact jason sells
Regulation Number 888.3660
Classification Product Code
KWS  
Date Received 04/09/2008
Decision Date 09/05/2008
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