SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM


Device Classification Name

prosthesis, shoulder, hemi-, humeral, metallic uncemented

510(k) Number K072578
Device Name SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
Applicant
SYNTHES (USA)
1302 wrights lane east
west chester, 
PA 
19380

Applicant Contact sheri musgnung
Correspondent
SYNTHES (USA)
1302 wrights lane east
west chester, 
PA 
19380

Correspodent Contact sheri musgnung
Regulation Number 888.3690
Classification Product Code
HSD  
Subsequent Product Codes
KWT   MBF  
Date Received 09/13/2007
Decision Date 11/28/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No