Atlas FDA

IQM

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Splint, Temporary Training
Device class
Class I (low risk)
Regulation
21 CFR 890.3025
Medical specialty
Physical Medicine
Flags
GMP exempt
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RecordFirmDate
FINGEO EXTENSION SPLINTS (K771287)Fred Sammons, Inc.1977-07-21
SPLINH, FOREARM (K770891)Orthopedic Systems, Inc.1977-05-26
SPLINT, COCKUP (K770890)Orthopedic Systems, Inc.1977-05-26

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