CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM


Device Classification Name

prosthesis, shoulder, hemi-, humeral, metallic uncemented

510(k) Number K023096
Device Name CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM
Original Applicant
STD MFG., INC.
1063 turnpike st.
p.o. box 420
stoughton, 
MA 
02072

Original Contact steve ek
Regulation Number 888.3690
Classification Product Code
HSD  
Date Received 09/18/2002
Decision Date 04/10/2003
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