LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT— 510(k) K011554

Name: FDA 510(k) clearance K011554
Creator: U.S. Food and Drug Administration
Published: 2001-06-26

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K011554 for LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT, Substantially Equivalent on 2001-06-26. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code MIX
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2001-05-18
Decision date: 2001-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MIX

view all

K240919 — Silk Voice (SMI-04)2024-05-03
K180631 — Silk Voice2018-11-08
K150400 — Renu Gel2015-04-06
K121795 — CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT2013-02-22
K083783 — VF LIQUIGEL2009-09-11

More clearances from Biomet, Inc.

view all

K253434 — OSSTM Orthopedic Salvage System2026-07-01
K251270 — Taperloc® Complete Hip Stem2026-05-19
K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

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