Data / Medical devices / Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation / United States
FDA-registered makers of Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation (product code OIS). 2 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
- Product code
- OIS
- Country
- United States
Makers of Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 1 | July 2, 2008 | 0 | 1 | 0 | api.fda.gov |
| Abyrx, Inc. | Stamford, CT, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bone Solutions, Inc. | Colleyville, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DSM Biomedical, Inc. | Exton, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract 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.