TORNIER CEMENT RESTRICTOR— 510(k) K061824

Substantially Equivalent

Tornier

FDA 510(k) clearance K061824 for TORNIER CEMENT RESTRICTOR, Substantially Equivalent on 2006-09-14. Applicant: Tornier. Device class: 2.

Clearance details

Applicant: Tornier
Product code: Code LZN
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2006-06-28
Decision date: 2006-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint-Ismier Cedex, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZN

K220838 — Artisan Bone Plug, Universal Cement Restrictor2022-05-20
K032685 — CEMSTOP CEMENT RESTRICTOR2003-11-26
K023680 — BIOBUCK CEMENT RESTRICTOR2002-11-19
K011943 — IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR2001-09-19
K010840 — SYNPLUG2001-04-20

More clearances from Tornier

K112144 — AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS2012-03-13
K111970 — KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT2012-02-23
K111902 — AEQUALIS SHOULDER SYSTEM2011-11-03
K094013 — HLS KNEETEC SYSTEM2011-05-05
K100142 — AEQUALIS REVERSED SHOULDER PROSTHESIS2010-05-06

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