Atlas FDA

HXJ

6 FDA 510(k) clearances · Product code

70 daysmedian time to decision
199 days90th percentile
6clearances measured

FDA profile

Official device name
Staple Driver
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Medical specialty
Orthopedic
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RecordFirmDate
IN-TAC BONE ANCHOR SYSTEM (K964953)Influence, Inc.1997-02-13
UROTAC BONE ANCHOR INSERTER (K962372)Influence, Inc.1996-08-19
ELECTRIC WIRE DRIVER, MODEL 2640E (K930205)Micro Surgical Instruments Corp.1993-08-02
FIXATION STAPLE KIT - DLIDE HAMMER (K834515)Stryker Corp.1984-04-23
OSTEOTOMY BONE STAPLE (K830255)Techmedica, Inc.1983-03-09
STAPLE INSERTER-EXTRACTOR FOR ARTHROS (K830456)Instrument Makar, Inc.1983-03-09

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