BIOPRO RIMMED ACETABULAR COMPOMENT


Device Classification Name

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

510(k) Number K992144
Device Name BIOPRO RIMMED ACETABULAR COMPOMENT
Applicant
BIOLOGICALLY ORIENTED PROSTHESES
17 seventeenth st.
port huron, 
MI 
48060

Applicant Contact angena parekh
Correspondent
BIOLOGICALLY ORIENTED PROSTHESES
17 seventeenth st.
port huron, 
MI 
48060

Correspodent Contact angena parekh
Regulation Number 888.3353
Classification Product Code
LZO  
Subsequent Product Code
JDI  
Date Received 06/24/1999
Decision Date 09/22/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No