Device Classification Name |
prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
|
510(k) Number |
K013035 |
Device Name |
GUARDIAN LIMB SALVAGE SYSTEM |
Applicant |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Applicant Contact |
EHAB M ESMAIL |
Correspondent |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Correspondent Contact |
EHAB M ESMAIL |
Regulation Number | 888.3510
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/10/2001 |
Decision Date | 12/07/2001 |
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
|
|
|