Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, uncemented
|
510(k) Number |
K955553 |
Device Name |
PERFECTA REVISION HIP SYSTEM |
Applicant |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Applicant Contact |
CLIFF R KLINE II |
Correspondent |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Correspondent Contact |
CLIFF R KLINE II |
Regulation Number | 888.3360
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/05/1995 |
Decision Date | 10/24/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|