SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS


Device Classification Name

prosthesis, shoulder, hemi-, humeral, metallic uncemented

510(k) Number K121714
Device Name SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Applicant Contact bradley heil
Correspondent
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Correspodent Contact bradley heil
Regulation Number 888.3690
Classification Product Code
HSD  
Subsequent Product Code
KWS  
Date Received 06/11/2012
Decision Date 09/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No