The following data is part of a premarket notification filed by C.r. Bard Inc. 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 | K170278 |
| 510k Number | K170278 |
| 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 | 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 | 2017-01-30 |
| Decision Date | 2017-05-31 |
| Summary: | summary |