FDA product code OBL: Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
OBL is the FDA product code for cement, bone, pre-formed, modular, polymeric, vertebroplasty. It is a Class II device, regulated under 21 CFR 888.3027 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under OBL. The average 510(k) review took 133 days (median 133).
Definition
Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.
Classification
| Field | Value |
|---|---|
| Device name | Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty |
| Device class | Class II |
| Regulation | 21 CFR 888.3027 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every OBL clearance
Top OBL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spine Wave, Inc. | 1 | 2007-04-13 |
Most recent OBL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K063606 | Spine Wave, Inc. | MODIFICATION TO STAXX FX SYSTEM | 2007-04-13 | 133 |
Recalls for OBL devices
openFDA lists no recalls for product code OBL.
Frequently asked questions
What is FDA product code OBL?
OBL is the FDA product code for cement, bone, pre-formed, modular, polymeric, vertebroplasty. It is a Class II device, regulated under 21 CFR 888.3027 and reviewed by the Orthopedic panel.
What device class is OBL?
Class II, regulation 21 CFR 888.3027. Typical premarket route: 510(k).
How long does a 510(k) take for product code OBL?
Across 1 cleared submissions the average was 133 days from receipt to decision (median 133).
Which companies have the most OBL clearances?
Spine Wave, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OBL
- Run a recall and safety report across every OBL manufacturer
- Watch product code OBL 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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