Atlas FDA

HTP

5 FDA 510(k) clearances · Product code

85 daysmedian time to decision
294 days90th percentile
5clearances measured

FDA profile

Official device name
File
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Medical specialty
Orthopedic
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RecordFirmDate
INTERMEDICS ORTHOPEDICS REAMERS (K931733)Intermedics Orthopedics1994-01-26
SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP (K870842)Warsaw Orthopedic, Inc.1987-05-27
CONCEPT ARTHROSCOPY RASP (K862659)Concept, Inc.1986-09-02
4MM & 5MM FILE (K841981)Stainless Mfg., Inc.1984-06-19
SUN-LITE BLUE SLIT (K840492)Suncoast Medical Manufacturers, Inc.1984-05-09

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