Data / Medical devices / Screw, Fixation, Intraosseous / United States
FDA-registered makers of Screw, Fixation, Intraosseous in the United States: 25 establishments
25 establishments in the United States are registered with the FDA to make Screw, Fixation, Intraosseous (product code DZL). 9 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Screw, Fixation, Intraosseous
- Product code
- DZL
- Country
- United States
Makers of Screw, Fixation, Intraosseous in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 13 | January 25, 2010 | 0 | 1 | 0 | api.fda.gov |
| Biohorizons Implant Systems Inc. | Birmingham, AL, United States | Complaint file establishment, Manufacturer | 4 | August 28, 2002 | 0 | 0 | 0 | api.fda.gov |
| KLS-Martin L.P. | Jacksonville, FL, United States | Specification developer | 4 | September 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Osteomed | Addison, TX, United States | Manufacturer | 4 | September 21, 2015 | 0 | 0 | 0 | api.fda.gov |
| Salvin Dental Specialties, LLC | Charlotte, NC, United States | Repackager or relabeler, Specification developer | 3 | April 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Biomet Microfixation | Jacksonville, FL, United States | Manufacturer, Specification developer | 1 | May 13, 1999 | 0 | 1 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Contract manufacturer, Manufacturer | 1 | October 2, 2014 | 0 | 0 | 0 | api.fda.gov |
| Kinamed, Inc. | Camarillo, CA, United States | Manufacturer | 1 | September 8, 1998 | 0 | 0 | 0 | api.fda.gov |
| Osteogenics Biomedical, Inc. | Lubbock, TX, United States | Manufacturer | 1 | March 1, 2010 | 0 | 0 | 0 | api.fda.gov |
| 3D MEDICAL MANUFACTURING, INC. (dba Tecomet) | Riviera Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam West LLC | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Impladent, Ltd. | Northborough, MA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Brandywine) | W Chester, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Elmira) | Horseheads, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Monument) | Monument, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mci Medical Concept Innovation Inc. | Sunrise, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision One Medical | Oceanside, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision One Medical | Hoover, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Aspirators, Inc. | Dallas, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Aspirators, Inc. | Duncanville, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quintus, Inc. | Camp Verde, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecomet | Woburn, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Visionare LLC | Fort Myers, FL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| X-Nav Technologies, LLC. | Lansdale, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.