Instrument, Surgical, Sonic And Accessory/attachment

Product Code: JDX

Orthopedic Diagnostic Ultrasound Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 888.4580


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as JDX

4535Instrument, Surgical, Sonic And Accessory/attachmentSonic Surgical Instrument And Accessories/attachments.

Total Product Life Cycle (TPLC) Devices

4535Instrument, Surgical, Sonic And Accessory/attachmentSonic Surgical Instrument And Accessories/attachments.

FDA Consensus Standards

Instrument, Surgical, Sonic And Accessory/Attachment [37411]21 CFR §888.4580 🔎

Pre-market Notifications for JDX

K201274Ultrasonic Osteotomy Surgical SystemSMTP Technology Co., Ltd
K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium
K163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSATALEC-ACTEON GROUP
K153743PIEZOSURGERY PLUSMECTRON SPA
K132848PIEZOSURGERY FLEXMECTRON S.P.A.
K100410PIEZOELECTRIC SYSTEMSATELEC
K093805OSCAR 3ORTHOSONICS, LTD.
K083284PIEZOSURGERY MEDICALPIEZOSURGERY SRL
K051053OSCAR, MODEL OE3000DBORTHOSONICS, LTD.
K031280ULTRA-DRIVE 3BIOMET, INC.
K022729VENTED CEMENT RESTRICTORAMEDICA CORP.
K002484EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVALELECTRO MEDICAL SYSTEMS SA
K961725OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISIONC.L. MCINTOSH & ASSOC., INC.
K930109KOMET MEDICAL SURGICAL POWER ACCESORIESBRASSLER USA
K912931ITM SONIC SURGERY SYSTEMBUCKMAN CO., INC.

Global Unique Device Identification Database

00880304372917INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT
05060201560579Instrument, Surgical, Sonic And Accessory/Attachment
05060201560340Instrument, Surgical, Sonic And Accessory/Attachment
18053800898178Instrument, Surgical, Sonic And Accessory/Attachment
18053800898161Instrument, Surgical, Sonic And Accessory/Attachment
18053340341820Instrument, Surgical, Sonic And Accessory/Attachment
18053340341813Instrument, Surgical, Sonic And Accessory/Attachment
18053340341806Instrument, Surgical, Sonic And Accessory/Attachment
18053340341790Instrument, Surgical, Sonic And Accessory/Attachment
18053340341783Instrument, Surgical, Sonic And Accessory/Attachment
18053340341776Instrument, Surgical, Sonic And Accessory/Attachment
18053340341769Instrument, Surgical, Sonic And Accessory/Attachment
18053340341752Instrument, Surgical, Sonic And Accessory/Attachment
18053340341745Instrument, Surgical, Sonic And Accessory/Attachment
18053340341738Instrument, Surgical, Sonic And Accessory/Attachment

Maude Adverse Events

ULTRA-DRIVE 9.5 SHORT OSTEOTOMZIMMER BIOMET, INC.2020-03-26
ULTRA DRIVE 5MM HOEZIMMER BIOMET, INC.2020-03-26
ULTRA DRIVE 60MM TIP EXTENDERZIMMER BIOMET, INC.2020-03-26
5MM REVERSE CURETTEZIMMER BIOMET, INC.2020-03-26
OSCAR - LONG EXTENSION REDUCER BAR FOR SINGLE USE PROBESORTHOFIX SRL2020-02-27
SINGLE USE 6MM PIERCER PROBE - SLIM - 180MM - STERILEORTHOFIX SRL2019-10-31
PIZOSURGERYMECTRON S.P.A.2019-10-17
IRRIGATION TUBING ASSEMBLYZIMMER BIOMET, INC.2019-09-18
INSERT MT1S-10MECTRON S.P.A.2019-08-09
GEN CASEFRAME OPTICAL 230VORTHOFIX SRL2019-07-05
SINGLE USE 6MM PIERCER PROBE - SLIM - 180MM - STERILEORTHOFIX SRL2019-07-04
OSCARORTHOFIX SRL2019-07-02
CEMENT REMOVAL HANDSETORTHOFIX SRL2019-05-02
CABLEORTHOFIX SRL2019-05-02
ULTRASONIC GENERATOR 230V CEORTHOFIX SRL2019-05-02
ULTRASONIC GENERATOR 230V CEORTHOFIX SRL2019-05-02
CABLEORTHOFIX SRL2019-05-02
CEMENT REMOVAL HANDSETORTHOFIX SRL2019-05-02
GEN CASEFRAME NON OPTICAL 230VORTHOFIX SRL2019-03-12
CEMENT REMOVAL HANDSETORTHOFIX SRL2019-02-26
ULTRASONIC GENERATOR 230V CEORTHOFIX SRL2019-02-26
CEMENT REMOVAL HANDSETORTHOFIX SRL2019-02-26
HANDSET FOR OSCAR IIORTHOFIX SRL2019-02-25
PIEZOSURGERYMECTRON S.P.A.2019-02-20
PIEZOSURGERYMECTRON S.P.A.2019-02-20
PIEZOSURGERYMECTRON S.P.A.2019-02-20
PIEZOSURGERYMECTRON S.P.A.2019-02-19
CEMENT REMOVAL HANDSETORTHOFIX SRL2019-02-13
PIEZOSURGERYMECTRON S.P.A.2019-02-11
PIEZOSURGERYMECTRON S.P.A.2019-02-08
CEMENT REMOVAL HANDSETORTHOFIX SRL2019-01-30
PROBEORTHOFIX SRL2019-01-30
CEMENT REMOVAL HANDSETORTHOFIX SRL2019-01-30
CEMENT REMOVAL HANDSETORTHOFIX SRL2019-01-30
CABLEORTHOFIX SRL2019-01-16
ULTRASONIC GENERATOR 230V CEORTHOFIX SRL2019-01-16
ULTRASONIC GENERATOR 230V CEORTHOFIX SRL2019-01-16
CEMENT REMOVAL HANDSETORTHOFIX SRL2019-01-07
ULTRASONIC GENERATOR 230V CEORTHOFIX SRL2019-01-07
PIEZOSURGERYMECTRON S.P.A.2018-12-14
ULTRA-DRIVE DISK DRILLZIMMER BIOMET, INC.2018-12-11
ULTRA-DRIVE DISK DRILLZIMMER BIOMET, INC.2018-12-11
ULTRA DRIVE TIP EXTENDERZIMMER BIOMET, INC.2018-12-11
ULTRA-DRIVE DISC DRILLZIMMER BIOMET, INC.2018-12-11
ULTRA-DRIVE TIP EXTENDERZIMMER BIOMET, INC.2018-12-11
ULTRA-DRIVE TIP EXTENDERZIMMER BIOMET, INC.2018-12-11
ULTRA DRIVE DISK DRILLZIMMER BIOMET, INC.2018-12-11
BONECUTTER OSTEOTOME HANDSETORTHOFIX SRL2018-12-04
SINGLE USE 8MM SCRAPER PROBE - 80MM - STERILEORTHOFIX SRL2018-12-04
CEMENT REMOVAL HANDSETORTHOFIX SRL2018-11-08
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