EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM


Device Classification Name

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

510(k) Number K023646
Device Name EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM
Original Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Original Contact lisa simpson
Regulation Number 888.3350
Classification Product Code
JDI  
Date Received 10/30/2002
Decision Date 11/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Special
Reviewed by Third Party No

Combination Product

No