OSTEONICS FX-CABLELOK GRIP COMPONENTS— 510(k) K980594

Name: FDA 510(k) clearance K980594
Creator: U.S. Food and Drug Administration
Published: 1998-05-05

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K980594 for OSTEONICS FX-CABLELOK GRIP COMPONENTS, Substantially Equivalent on 1998-05-05. Applicant: Osteonics Corp.. Device class: 2.

Clearance details

Applicant: Osteonics Corp.
Product code: Code LYT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1998-02-17
Decision date: 1998-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYT

view all

K040363 — CERAMIC TIPPED SKULL PIN2004-04-12
K983685 — BONE BAND1998-12-04
K914812 — K-CAP-E, STERILE1992-01-09
K912762 — K-CAP-I, STERILE1991-07-18
K902053 — K-CAP-I ORTHOPEDIC FIXATION WIRE CAP1990-09-14

More clearances from Osteonics Corp.

view all

K983657 — OSTEONICS SERIES 7000 AD TIBIAL TRAY2000-04-06
K980070 — OSTEONICS HA-COATED DEVICES1999-07-23
K984375 — OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY1999-04-30
K982798 — OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM1999-03-25
K984585 — OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE1999-02-24

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