ASCENDENT ACETABULAR SYSTEM


Device Classification Name

prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

510(k) Number K022985
Device Name ASCENDENT ACETABULAR SYSTEM
Original Applicant
SULZER ORTHOPEDICS, INC.
9900 spectrum dr.
austin, 
TX 
78717

Original Contact frances e harrison
Regulation Number 888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDJ   KWA   LWJ  
Date Received 09/09/2002
Decision Date 12/05/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls