Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K192750 |
Device Name |
AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip |
Applicant |
Parcus Medical, LLC |
6423 Parkland Dr |
Sarasota,
FL
34243
|
|
Applicant Contact |
Paul Vagts |
Correspondent |
Parcus Medical, LLC |
6423 Parkland Dr |
Sarasota,
FL
34243
|
|
Correspondent Contact |
Paul Vagts |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 09/30/2019 |
Decision Date | 01/16/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|