The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Sorbafix (tm) Absorbable Fixation System, Permafix (tm) Fixation System.
| Device ID | K111153 |
| 510k Number | K111153 |
| Device Name: | SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM |
| Classification | Staple, Implantable |
| Applicant | C.R. BARD, INC. 100 CROSSINGS BOULEVARD Warwick, RI 02886 |
| Contact | Zheng Liu |
| Correspondent | Zheng Liu C.R. BARD, INC. 100 CROSSINGS BOULEVARD 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 | 2011-04-25 |
| Decision Date | 2011-05-24 |
| Summary: | summary |