Atlas FDA

SFD

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
In Situ Polymerizing Peripheral Nerve Repair Device
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5270
Medical specialty
Neurology
Flags
Implant
FDA definition
An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries.
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RecordFirmDate
Coaptium Connect with Tissium Light (K251957)Tissium SA2025-09-08
COAPTIUM Connect with TISSIUM LIGHT (DEN240066)Tissium SA2025-06-17

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Every clearance here is in the API, with alerts when new ones post.