The following data is part of a premarket notification filed by Davol Inc., Subsidiary Of C.r. Bard with the FDA for Optifix At Absorbable Fixation System With Articulating Technology – 30 Fasteners, Optifix At Absorbable Fixation System With Articulating Technology – 15 Fasteners.
| Device ID | K191287 |
| 510k Number | K191287 |
| Device Name: | OptiFix AT Absorbable Fixation System With Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System With Articulating Technology – 15 Fasteners |
| Classification | Staple, Implantable |
| Applicant | Davol Inc., Subsidiary Of C.R. Bard 100 Crossings Blvd Warwick, RI 02886 |
| Contact | Angelica Hutchison |
| Correspondent | Angelica Hutchison Davol Inc., Subsidiary Of C.R. Bard 100 Crossings Blvd Warwick, RI 02886 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-13 |
| Decision Date | 2019-07-16 |