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FDA 510(k)

VOCOM IMPLANT- 8MM

K-Number: K000533 · 2000-03-01

ApplicantSmith & Nephew, Inc.
Decision Date2000-03-01
Product CodeMIX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VOCOM IMPLANT- 8MM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2000-03-01 under 510(k) number K000533. 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 VOCOM IMPLANT- 8MM?

VOCOM IMPLANT- 8MM is a medical device that received FDA 510(k) clearance on 2000-03-01. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K000533.

When did VOCOM IMPLANT- 8MM receive FDA 510(k) clearance?

VOCOM IMPLANT- 8MM received FDA 510(k) clearance on 2000-03-01, under 510(k) number K000533.

Who is the listed applicant for VOCOM IMPLANT- 8MM?

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

What is the FDA product code for VOCOM IMPLANT- 8MM?

The FDA product code for VOCOM IMPLANT- 8MM is MIX.

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Other records listing Smith & Nephew, Inc. as applicant

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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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