THE ARTHROFILE— 510(k) K812506

Substantially Equivalent

Dyonics, Inc.

FDA 510(k) clearance K812506 for THE ARTHROFILE, Substantially Equivalent on 1981-09-24. Applicant: Dyonics, Inc.. Device class: 1.

Clearance details

Applicant: Dyonics, Inc.
Product code: Code HTR
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1981-09-01
Decision date: 1981-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code HTR

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K813093 — RICHARDS ACETABULAR BRUSH1981-11-20
K780771 — MICRO RASPS1978-05-16

More clearances from Dyonics, Inc.

K900070 — MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM1990-02-16
K896416 — DYONICS SHOULDER PORTAL SYSTEM1990-01-02
K893136 — SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY1989-12-14
K890665 — MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES1989-11-03
K894728 — DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE1989-08-18

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