KOMET MEDICAL SURGICAL POWER ACCESORIES— 510(k) K930109

Name: FDA 510(k) clearance K930109
Creator: U.S. Food and Drug Administration
Published: 1993-08-25

Substantially Equivalent

Brassler USA

FDA 510(k) clearance K930109 for KOMET MEDICAL SURGICAL POWER ACCESORIES, Substantially Equivalent on 1993-08-25. Applicant: Brassler USA. Device class: 2.

Clearance details

Applicant: Brassler USA
Product code: Code JDX
Device class: Class 2
Regulation: 21 CFR 888.4580
Advisory panel: Orthopedic
Date received: 1993-01-11
Decision date: 1993-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDX

view all

K201274 — Ultrasonic Osteotomy Surgical System2021-02-19
K172464 — XD880A Ultrasonic Osteotomy Surgical System2018-04-24
K163610 — PIEZOTOME M+, PIEZOTOME M+ Handpiece2017-05-19
K153743 — PIEZOSURGERY PLUS2016-05-25
K132848 — PIEZOSURGERY FLEX2013-11-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.