Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K191459 |
Device Name |
JuggerStitch Meniscal Repair Device |
Applicant |
Biomet Inc. |
56 East Bell Drive |
Warsaw,
IN
46581
|
|
Applicant Contact |
Kyle Ponce |
Correspondent |
Biomet Inc. |
56 East Bell Drive |
Warsaw,
IN
46581
|
|
Correspondent Contact |
Kyle Ponce |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 06/03/2019 |
Decision Date | 09/13/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|