Device Classification Name |
prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
|
510(k) Number |
K133940 |
Device Name |
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) |
Applicant |
BIOMET UK LTD. |
56 EAST BELL DRIVE |
WARSAW,
IN
46581
|
|
Applicant Contact |
JASON HECKAMAN |
Correspondent |
BIOMET UK LTD. |
56 EAST BELL DRIVE |
WARSAW,
IN
46581
|
|
Correspondent Contact |
JASON HECKAMAN |
Regulation Number | 888.3530
|
Classification Product Code |
|
Date Received | 12/23/2013 |
Decision Date | 03/28/2014 |
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
|
|
|