CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM


Device Classification Name

prosthesis, hip, femoral, resurfacing

510(k) Number K021549
Device Name CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM
Original Applicant
STD MFG., INC.
1063 turnpike st.
p.o. box 420
stoughton, 
MA 
02072

Original Contact steve ek
Regulation Number 888.3400
Classification Product Code
KXA  
Date Received 05/13/2002
Decision Date 08/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No