Atlas FDA

JDX

23 FDA 510(k) clearances · Product code

90 daysmedian time to decision
226 days90th percentile
23clearances measured

FDA profile

Official device name
Instrument, Surgical, Sonic And Accessory/Attachment
Device class
Class II (moderate risk)
Regulation
21 CFR 888.4580
Medical specialty
Orthopedic
Adverse events (MAUDE)
2002: 2 · 2013: 7 · 2014: 16 · 2018: 42 · 2019: 34 · 2020: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Ultrasonic Osteotomy Surgical System (K201274)Smtp Technology Co., Ltd.2021-02-19
XD880A Ultrasonic Osteotomy Surgical System (K172464)Morley Research Consortium2018-04-24
PIEZOTOME M+, PIEZOTOME M+ Handpiece (K163610)Satalec-Acteon Group2017-05-19
PIEZOSURGERY PLUS (K153743)Mectron S.P.A.2016-05-25
PIEZOSURGERY FLEX (K132848)Mectron S.P.A.2013-11-29
PIEZOELECTRIC SYSTEM (K100410)Satelec2010-04-28
OSCAR 3 (K093805)Orthosonics, Ltd.2010-02-19
PIEZOSURGERY MEDICAL (K083284)Piezosurgery S.R.L.2009-04-08
OSCAR BONE RESECTOR (K083830)Orthosonics, Ltd.2009-03-20
LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) (K072961)Sra Developments, Ltd.2007-12-19
OSCAR, MODEL OE3000DB (K051053)Orthosonics, Ltd.2005-07-21
ULTRA-DRIVE 3 (K031280)Biomet, Inc.2003-09-22
VENTED CEMENT RESTRICTOR (K022729)Amedica Corp.2002-11-14
EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL (K002484)Electro Medical Systems SA2000-10-04
OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION (K961725)C.L. Mcintosh & Assoc., Inc.1996-08-01
KOMET MEDICAL SURGICAL POWER ACCESORIES (K930109)Brassler USA1993-08-25
ITM SONIC SURGERY SYSTEM (K912931)Buckman Co., Inc.1991-10-03
ACRYL-X SYSTEM TM (K911548)Sonokinetics, Inc.1991-06-28
SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE (K905451)Advanced Osseous Technologies1991-03-05
SYSTEM TEN MODEL 100 SURGICAL SYSTEM (K900003)Advanced Osseous Technologies1990-03-16
MODIFIED PROFILE HIP ACETABULAR PROSTHESIS (K891408)Depuy, Inc.1989-06-12
ACE MOS SAW AND THE ACE MOS SPINE SAW (K862504)Buckman Co., Inc.1986-08-07
PFIZER/AS&E 0450 LOCALIZER (K800501)Pfizer Medical Systems, Inc.1980-04-10

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