The following data is part of a premarket notification filed by C.r.bard Inc. with the FDA for Optifix Fixation System - Straight 5mm X 39 Cm - 30 Absorbable Fasteners, Optifix Fixation System - Straight 5mm X 39 Cm - 15 Absorbable Fasteners.
| Device ID | K142873 |
| 510k Number | K142873 |
| Device Name: | OptiFix Fixation System - Straight 5mm X 39 Cm - 30 Absorbable Fasteners, OptiFix Fixation System - Straight 5mm X 39 Cm - 15 Absorbable Fasteners |
| Classification | Staple, Implantable |
| Applicant | C.R.Bard Inc. 100 Crossings Boulevard Warwick, RI 02886 |
| Contact | Christine Lloyd |
| Correspondent | Christine Lloyd 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 | 2014-10-01 |
| Decision Date | 2015-03-12 |
| Summary: | summary |