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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 the device name listed in this FDA 510(k) record. The listed applicant is Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2016-12-01 under 510(k) 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. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K161548.

When did Osseointegrated Fixtures receive FDA 510(k) clearance?

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

Who is the listed applicant for Osseointegrated Fixtures?

The FDA 510(k) record lists Southern Implants (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Osseointegrated Fixtures?

The FDA product code for Osseointegrated Fixtures is FZE.

Other records listing Southern Implants (Pty), Ltd. as applicant

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Related Devices (Code: FZE)

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.

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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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