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FDA 510(k)

TIB Abutment System

K-Number: K193084 · 2020-10-27

Decision Date2020-10-27
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TIB Abutment System 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 2020-10-27 under 510(k) number K193084. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIB Abutment System?

TIB Abutment System is a medical device that received FDA 510(k) clearance on 2020-10-27. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K193084.

When did TIB Abutment System receive FDA 510(k) clearance?

TIB Abutment System received FDA 510(k) clearance on 2020-10-27, under 510(k) number K193084.

Who is the listed applicant for TIB Abutment System?

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 TIB Abutment System?

The FDA product code for TIB Abutment System is NHA.

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

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.

View all 19 devices →

Related Devices (Code: NHA)

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.

Official Source

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