FDA product code PXR: Cement And Bone Removal Kit
PXR is the FDA product code for cement and bone removal kit. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. Devices under PXR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Cement And Bone Removal Kit |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for PXR devices
openFDA lists no recalls for product code PXR.
Frequently asked questions
What is FDA product code PXR?
PXR is the FDA product code for cement and bone removal kit. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel.
What device class is PXR?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PXR
- Run a recall and safety report across every PXR manufacturer
- Watch product code PXR 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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