OSTEONICS RESTORATION ACETABULAR RING— 510(k) K970957

Name: FDA 510(k) clearance K970957
Creator: U.S. Food and Drug Administration
Published: 1997-06-03

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K970957 for OSTEONICS RESTORATION ACETABULAR RING, Substantially Equivalent on 1997-06-03. Applicant: Osteonics Corp.. Device class: 2.

Clearance details

Applicant: Osteonics Corp.
Product code: Code JDJ
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1997-03-17
Decision date: 1997-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDJ

view all

K972760 — LINK, ACETABULAR REVISION MESH CUP1997-10-22
K963940 — EXETER MESH1997-02-13
K962541 — REFLECTION ACETABULAR REINFORCEMENT RINGS1996-09-17
K962007 — PROTRUSION CAGES1996-08-01
K925883 — OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS1993-06-15

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.