The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Bioresorbable Fixation System.
| Device ID | K012486 |
| 510k Number | K012486 |
| Device Name: | OSTEOMED BIORESORBABLE FIXATION SYSTEM |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | OSTEOMED CORP. 3750 REALTY RD. Addison, TX 75001 -4311 |
| Contact | Dawn T Holdeman |
| Correspondent | Dawn T Holdeman OSTEOMED CORP. 3750 REALTY RD. Addison, TX 75001 -4311 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-02 |
| Decision Date | 2002-01-16 |
| Summary: | summary |