Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K920955 |
Device Name |
APR(R) HIP SYST & NATURAL-HIP(R) FOR UNCEMENT USE |
Applicant |
INTERMEDICS ORTHOPEDICS |
1300 EAST ANDERSON LN. |
BUILDING C |
AUSTIN,
TX
78752
|
|
Applicant Contact |
WEBB |
Correspondent |
INTERMEDICS ORTHOPEDICS |
1300 EAST ANDERSON LN. |
BUILDING C |
AUSTIN,
TX
78752
|
|
Correspondent Contact |
WEBB |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/26/1992 |
Decision Date | 02/09/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|