Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K130033 |
Device Name |
TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO |
Applicant |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
ELIZABETH WRAY |
Correspondent |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
ELIZABETH WRAY |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/04/2013 |
Decision Date | 08/01/2013 |
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
|
|
|