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FDA 510(k)

LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT

K-Number: K011554 · 2001-06-26

ApplicantBiomet, Inc.
Decision Date2001-06-26
Product CodeMIX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2001-06-26 under 510(k) number K011554. The device is classified under product code MIX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT?

LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT is a medical device that received FDA 510(k) clearance on 2001-06-26. The listed applicant is Biomet, Inc.. The 510(k) number is K011554.

When did LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT receive FDA 510(k) clearance?

LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT received FDA 510(k) clearance on 2001-06-26, under 510(k) number K011554.

Who is the listed applicant for LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT?

The FDA 510(k) record lists Biomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT?

The FDA product code for LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT is MIX.

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Related Devices (Code: MIX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240919Silk Voice (SMI-04)Sofregen MedicalK180631Silk VoiceSofregen Medical, Inc.K121795CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANTCytophil, Inc.K083783VF LIQUIGELCoapt Systems, Inc.K081815VOCALIS GELCytophil, Inc.K081816VOCALIS AND VOCALIS SMCytophil, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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