Device Classification Name |
staple, implantable
|
510(k) Number |
K191287 |
Device Name |
OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners |
Applicant |
Davol Inc., Subsidiary of C.R. Bard |
100 Crossings Blvd |
Warwick,
RI
02886
|
|
Applicant Contact |
Angelica Hutchison |
Correspondent |
Davol Inc., Subsidiary of C.R. Bard |
100 Crossings Blvd |
Warwick,
RI
02886
|
|
Correspondent Contact |
Angelica Hutchison |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 05/13/2019 |
Decision Date | 07/16/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|