5 catalogue numbers from SP-1989, listed by Biomet Microfixation, United States, under Screw, Fixation, Intraosseous. 3 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Screw, Fixation, Intraosseous | Listed by | Biomet Microfixation, United States |
| FDA product code | DZL |
| Device type | Screw, Fixation, Intraosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4880 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K983728 |
| Record published | 2015-10-11 |
| Record revised | 2025-05-30 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.