INTER-OP DURASUL ACETABULAR INSERTS (4MM)


codes

Device Classification Name

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

510(k) Number K002575
Device Name INTER-OP DURASUL ACETABULAR INSERTS (4MM)
Original Applicant
SULZER ORTHOPEDICS, INC.
9900 spectrum dr.
austin, 
TX 
78717

Original Contact mitchell a dhority
Regulation Number 888.3360
Classification Product Code
LWJ  
Subsequent Product Codes
JDI   LPH  
Date Received 08/18/2000
Decision Date 11/15/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No