INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM— 510(k) K022887

Name: FDA 510(k) clearance K022887
Creator: U.S. Food and Drug Administration
Published: 2002-11-26

Substantially Equivalent

Osteomed Corp.

FDA 510(k) clearance K022887 for INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM, Substantially Equivalent on 2002-11-26. Applicant: Osteomed Corp.. Device class: 2.

Clearance details

Applicant: Osteomed Corp.
Product code: Code KWH
Device class: Class 2
Regulation: 21 CFR 888.3720
Advisory panel: Orthopedic
Date received: 2002-08-30
Decision date: 2002-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, US

Download summary PDF View on FDA.gov ↗

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K023260 — 1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM2002-10-18
K013618 — INTRAORAL MANDIBULAR DISTRACTION SYSTEM2002-08-14

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