Atlas FDA

ITM

5 FDA 510(k) clearances · Product code

36 daysmedian time to decision
66 days90th percentile
5clearances measured

FDA profile

Official device name
Cage, Knee
Device class
Class I (low risk)
Regulation
21 CFR 890.3475
Medical specialty
Physical Medicine
Flags
GMP exempt
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RecordFirmDate
EXTENSION CONTROL KNEE ORTHOSIS (K832742)Orthomedics1983-09-20
POLI-AXIAL KNEE CAGE (K812064)Generation II Orthotics, Inc.1981-08-13
CAST BRWM, FRACTURE (K770900)Chase Mfg. Co.1977-07-21
FRACTURE CAST BRACE, POLY (K770899)Chase Mfg. Co.1977-07-21
IMPROVED KNEE DRESSING (K760573)Richard'S Medical Equip., Inc.1976-10-05

Track ITM automatically

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