The following data is part of a premarket notification filed by C.r. Bard Inc, with the FDA for Optifix Open Absorbable Fixation System - 20 Absorbable Fasteners.
| Device ID | K163698 |
| 510k Number | K163698 |
| Device Name: | OptiFix Open Absorbable Fixation System - 20 Absorbable Fasteners |
| Classification | Staple, Implantable |
| Applicant | C.R. BARD INC, 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Contact | Katherine Earle |
| Correspondent | Katherine Earle C.R. BARD INC, 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-29 |
| Decision Date | 2017-04-11 |
| Summary: | summary |