Data / Medical devices / Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside (QRR): 4 FDA-registered makers in 3 countries
4 establishments in 3 countries are registered with the FDA to make Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside (product code QRR, Class 2, 21 CFR 888.3046). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on March 13, 2024, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QRR
- Device class
- 2
- Regulation
- 888.3046
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Sweden | 1 |
| Poland | 1 |
Makers of Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bone Support AB | LUND Skane, Sweden | Complaint file establishment, Manufacturer | 2 | March 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Isomedix Operations Inc. | Whippany, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | Chester, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nolato Stargard Sp. z o.o. | Stargard Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 13, 2024. 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.