FDA product code OWZ: Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
OWZ is the FDA product code for mesh, surgical, absorbable, thoracic, chest wall reconstruction. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. Devices under OWZ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
For reinforcement of soft tissue where weakness exists during chest wall reconstruction.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for OWZ devices
openFDA lists no recalls for product code OWZ.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- V2790 — Amniotic membrane for surgical reconstruction, per procedure
Frequently asked questions
What is FDA product code OWZ?
OWZ is the FDA product code for mesh, surgical, absorbable, thoracic, chest wall reconstruction. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel.
What device class is OWZ?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OWZ
- Run a recall and safety report across every OWZ manufacturer
- Watch product code OWZ 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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