Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
|
510(k) Number |
K191783 |
Device Name |
Parcus Synd-EZ Ti |
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 |
|
Subsequent Product Code |
|
Date Received | 07/03/2019 |
Decision Date | 10/09/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|