510(k) clearances

ReneuRx™ (Neural Ice)

Brixton Biosciences · Orthopedic

DEN250067UnknownDirectSJA
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Third party flag
N
City
Cambridge
Advisory committee description
Orthopedic
Address 1
1000 Massachusetts Ave.
Address 2
Suite 101
Product code
SJA
Zip code
02138
Applicant
Brixton Biosciences
Decision date
2026-08-21
Decision code
DENG
Country code
US
Device name
ReneuRx™ (Neural Ice)
Advisory committee
OR
Contact
Olivier Kagan
K number
DEN250067
State
MA
Date received
2025-12-15
Review advisory committee
OR
Postal code
02138
Decision description
Unknown
Clearance type
Direct
Harmonized identifiers (openFDA)
Device name
Injectable For Thermal Treatment Of Musculoskeletal Pain
Medical specialty description
Orthopedic
Regulation number
888.3048
Device class
2
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.