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SJAClass II

Injectable For Thermal Treatment Of Musculoskeletal Pain

21 CFR 888.3048 / Orthopedic

SJA is the FDA product code for Injectable For Thermal Treatment Of Musculoskeletal Pain, a class II device type, regulated under 21 CFR 888.3048. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SJA
Device name
Injectable For Thermal Treatment Of Musculoskeletal Pain
FDA 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.
Regulation
21 CFR 888.3048
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SJA

By decision year
1 clearance under product code SJA with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SJA by decision year
YearClearances
20261

Applicants with the most clearances

Product code SJA
Applicants holding the most 510(k) clearances under product code SJA
ApplicantClearances
Brixton Biosciences1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code SJA.