SJA
- Product code
- SJA
- Device name
- Injectable For Thermal Treatment Of Musculoskeletal Pain
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3048
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
FDA classification 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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| DEN250067 | 2026-08-21 | Brixton Biosciences | ReneuRx (Neural Ice) | — |
Official FDA classification page: SJA
Classification and pathway per current FDA publications. Data from openFDA (CC0).