Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, cemented
|
510(k) Number |
K974054 |
Device Name |
DISTAL CENTRALIZER, EXETER II HIP SYSTEM |
Applicant |
HOWMEDICA, INC. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070 -2584
|
|
Applicant Contact |
FRANK MAAS |
Correspondent |
HOWMEDICA, INC. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070 -2584
|
|
Correspondent Contact |
FRANK MAAS |
Regulation Number | 888.3350
|
Classification Product Code |
|
Date Received | 10/27/1997 |
Decision Date | 12/23/1997 |
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
|
|
|