Atlas FDA

KIJ

29 FDA 510(k) clearances · Product code

87 daysmedian time to decision
425 days90th percentile
29clearances measured

FDA profile

Official device name
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2011: 1,080 · 2012: 615 · 2013: 288 · 2014: 36 · 2015: 36 · 2016: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SMARTO (K163308)Jeil Medical Corporation2016-12-27
INSURGICAL SINGLE USE POWER EQUIPMENT (K112599)Insurgical, LLC2012-11-06
SMARTO (K101563)Jeil Medical Corporation2010-12-17
STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT (K972367)Stryker Instruments1997-09-04
STRYKER 2115 REPLACEMENT BATTERY (2115) (K970378)Implant Resource, Inc.1997-04-30
ACUMED BONE GRAFT SYSTEM (K960711)Acu Med, Inc.1996-05-07
SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY (K951450)Strenumed, Inc.1995-05-17
S & S ORTHOPEDIC WIRE DRIVER 701 (K944488)S & S Orthopedic , Ltd.1995-03-02
ARTHREX GRAFT HARVESTING KIT (K941285)Arthrex, Inc.1994-11-14
THE OSTEOMED B POWER SYSTEM AND ACCESSORIES (K933101)Osteomed Corp.1994-11-07
R AND D BATTERY REPLACEMENT (K933337)R & D Batteries, Inc.1994-04-05
SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM (K931395)Micro Surgical Instruments Corp.1994-01-28
3M MAXI-DRIVER II DBATTERY POWERED SYSTEM (K932307)3M Health Care, Ltd.1994-01-07
MODIFIED SAW BLADES TO THE SAGITAL SAW (K884839)Dyonics, Inc.1988-12-07
STERNAL POWER AWL (K873766)Bowen & Company, Inc.1988-11-14
LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III (K864137)Bio-Rad1986-11-07
FLUTED SUCTION MENISCAL CUTTER (K850789)T. Korossurgical Instruments Corp.1985-06-28
EZ 502 (K844163)Aeg Power Tool Corp.1985-03-11
EZ 505 (K844162)Aeg Power Tool Corp.1985-03-11
MICRO-CRAFT OSCILLATING SAW HANDPIECE (K822790)Xomed, Inc.1982-10-22
INTRA-ARTICULAR SURGICAL SYSTEM (K820367)Dyonics, Inc.1982-05-07
POWER PACK (K800314)Black & Decker(Tm)1980-03-19
DUAL MPC CHARGER (K800315)Black & Decker(Tm)1980-03-19
450 DRILL/800 DRILL (K800311)Black & Decker(Tm)1980-02-22
150 DRIVER/REAMER (K800312)Black & Decker(Tm)1980-02-22
SAGITTAL SAW (K800313)Black & Decker(Tm)1980-02-22
DRILL, CORDLESS SURGICAL (K790063)Richard'S Medical Equip., Inc.1979-02-05
HMD-2000 BATTERY-POWERED MINI-DRILL, THE (K780645)Medishield, Inc.1978-05-03
INTRA-ARTICULAR SHAVER (K771218)Dyonics, Inc.1978-02-01

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