Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
|
510(k) Number |
K193092 |
Device Name |
TunneLoc Tibial Fixation Device |
Applicant |
Biomet Inc. |
56 East Bell Drive, PO Box 587 |
Warsaw,
IN
46582
|
|
Applicant Contact |
Haley Pioch |
Correspondent |
Biomet Inc. |
56 East Bell Drive, PO Box 587 |
Warsaw,
IN
46582
|
|
Correspondent Contact |
Haley Pioch |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/06/2019 |
Decision Date | 01/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|