Product code JDX— Orthopedic
ACE MOS SAW AND THE ACE MOS SPINE SAW
- Classification name
- Instrument, Surgical, Sonic And Accessory/Attachment
- Device class
- Class 2
- Regulation
- 21 CFR 888.4580
- Advisory panel
- Orthopedic
- Total cleared
- 23
- First cleared
- Most recent
Market context for product code JDX
FDA has cleared devices under product code JDX between 1980 and 2021, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2021
- 2018
- 2017
- 2016
- 2013
- 2010
- 2009
- 2007
- 2005
- 2003
- 2002
- 2000
- 1996
- 1993
- 1991
Top applicants under product code JDX
Recent clearances under product code JDX
- K201274 — Ultrasonic Osteotomy Surgical System
- K172464 — XD880A Ultrasonic Osteotomy Surgical System
- K163610 — PIEZOTOME M+, PIEZOTOME M+ Handpiece
- K153743 — PIEZOSURGERY PLUS
- K132848 — PIEZOSURGERY FLEX
- K100410 — PIEZOELECTRIC SYSTEM
- K093805 — OSCAR 3
- K083284 — PIEZOSURGERY MEDICAL
- K083830 — OSCAR BONE RESECTOR
- K072961 — LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)
- K051053 — OSCAR, MODEL OE3000DB
- K031280 — ULTRA-DRIVE 3
- K022729 — VENTED CEMENT RESTRICTOR
- K002484 — EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL
- K961725 — OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION
- K930109 — KOMET MEDICAL SURGICAL POWER ACCESORIES
- K912931 — ITM SONIC SURGERY SYSTEM
- K911548 — ACRYL-X SYSTEM TM
- K905451 — SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE
- K900003 — SYSTEM TEN MODEL 100 SURGICAL SYSTEM
- K891408 — MODIFIED PROFILE HIP ACETABULAR PROSTHESIS
- K862504 — ACE MOS SAW AND THE ACE MOS SPINE SAW
- K800501 — PFIZER/AS&E 0450 LOCALIZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.