FDA product code SJA: Injectable For Thermal Treatment Of Musculoskeletal Pain
SJA is the FDA product code for injectable for thermal treatment of musculoskeletal pain. It is a Class II device, regulated under 21 CFR 888.3048 and reviewed by the Orthopedic panel. Devices under SJA reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
An injectable for thermal treatment of musculoskeletal pain is an injectable device intended to inhibit sensory nerve signaling through exchange of thermal energy (e.g., cold temperatures). The device is injected into the extraneural space of the target nerve.
Classification
| Field | Value |
|---|---|
| Device name | Injectable For Thermal Treatment Of Musculoskeletal Pain |
| Device class | Class II |
| Regulation | 21 CFR 888.3048 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
Recalls for SJA devices
openFDA lists no recalls for product code SJA.
Frequently asked questions
What is FDA product code SJA?
SJA is the FDA product code for injectable for thermal treatment of musculoskeletal pain. It is a Class II device, regulated under 21 CFR 888.3048 and reviewed by the Orthopedic panel.
What device class is SJA?
Class II, regulation 21 CFR 888.3048. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SJA
- Run a recall and safety report across every SJA manufacturer
- Watch product code SJA 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times