The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Optifix Absorbable Fixation System.
| Device ID | K132134 |
| 510k Number | K132134 |
| Device Name: | OPTIFIX ABSORBABLE FIXATION SYSTEM |
| Classification | Staple, Implantable |
| Applicant | C.R. BARD, INC. 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Contact | Radhika Pondicherry |
| Correspondent | Radhika Pondicherry 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 | 2013-07-11 |
| Decision Date | 2013-12-02 |
| Summary: | summary |