FDA product code QRR: Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
QRR is the FDA product code for filler, bone void, calcium compound containing single approved aminoglycoside. It is a Class II device, regulated under 21 CFR 888.3046 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under QRR, 1 in the last five years. The average 510(k) review took 85 days (median 85); 85 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial is a resorbable implant intended to fill bony defects of the extremities where there is an increased risk of infection. It is intended to resorb over time and be replaced by new bone. The product is intended for reduction of recurrence of chronic osteomyelitis of long bones. It is not intended to treat infection.
Classification
| Field | Value |
|---|---|
| Device name | Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside |
| Device class | Class II |
| Regulation | 21 CFR 888.3046 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for QRR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 85 |
Compare with all 510(k) review times · Search every QRR clearance
Top QRR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bonesupport AB | 1 | 2024-03-13 |
Most recent QRR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K234008 | Bonesupport AB | CERAMENT G | 2024-03-13 | 85 |
Recalls for QRR devices
openFDA lists no recalls for product code QRR.
Frequently asked questions
What is FDA product code QRR?
QRR is the FDA product code for filler, bone void, calcium compound containing single approved aminoglycoside. It is a Class II device, regulated under 21 CFR 888.3046 and reviewed by the Orthopedic panel.
What device class is QRR?
Class II, regulation 21 CFR 888.3046. Typical premarket route: 510(k).
How long does a 510(k) take for product code QRR?
Across 1 cleared submissions the average was 85 days from receipt to decision (median 85).
Which companies have the most QRR clearances?
Bonesupport AB (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QRR
- Run a recall and safety report across every QRR manufacturer
- Watch product code QRR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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