SJA — Injectable For Thermal Treatment Of Musculoskeletal Pain Class II
FDA product code SJA covers "Injectable For Thermal Treatment Of Musculoskeletal Pain", a Class II medical device regulated under 21 CFR 888.3048. Submissions are reviewed by the Orthopedic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SJA
- Device Class
- Class II
- Regulation Number
- 888.3048
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250067 | Brixton Biosciences | ReneuRx (Neural Ice) | Aug 21, 2026 |