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FDA 510(k)

Osseointegrated Fixtures

K-Number: K161548 · 2016-12-01

ApplicantSouthern Implants (Pty), Ltd.
Decision Date2016-12-01
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Osseointegrated Fixtures is a medical device manufactured by Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2016-12-01 under approval number K161548. The device is classified under product code FZE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Osseointegrated Fixtures?

Osseointegrated Fixtures is a medical device that received FDA 510(k) clearance on 2016-12-01. It is manufactured by Southern Implants (Pty), Ltd.. The 510(k) number is K161548.

When was Osseointegrated Fixtures approved by the FDA?

Osseointegrated Fixtures received FDA 510(k) clearance on 2016-12-01, under approval number K161548.

What company makes Osseointegrated Fixtures?

Osseointegrated Fixtures is manufactured by Southern Implants (Pty), Ltd..

What is the FDA product code for Osseointegrated Fixtures?

The FDA product code for Osseointegrated Fixtures is FZE.

Other Devices by Southern Implants (Pty), Ltd.

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Related Devices (Code: FZE)

K241253Medicon Epiplating SystemCmf Medicon Surgical, 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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