BICON-PLUS ACETABULAR COMPONENTS


Device Classification Name

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

510(k) Number K992154
Device Name BICON-PLUS ACETABULAR COMPONENTS
Applicant
PLUS ORTHOPEDICS
3550 general atomics ct.
bldg. 15-100
san diego, 
CA 
92121 -1122

Applicant Contact hartmut loch
Correspondent
PLUS ORTHOPEDICS
3550 general atomics ct.
bldg. 15-100
san diego, 
CA 
92121 -1122

Correspodent Contact hartmut loch
Regulation Number 888.3358
Classification Product Code
LPH  
Date Received 06/25/1999
Decision Date 04/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No