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FDA 510(k)

TS Abutment System

K-Number: K233194 · 2024-02-20

Decision Date2024-02-20
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TS Abutment System is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2024-02-20 under 510(k) number K233194. 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 TS Abutment System?

TS Abutment System is a medical device that received FDA 510(k) clearance on 2024-02-20. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K233194.

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

TS Abutment System received FDA 510(k) clearance on 2024-02-20, under 510(k) number K233194.

Who is the listed applicant for TS Abutment System?

The FDA 510(k) record lists Osstem Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TS Abutment System?

The FDA product code for TS Abutment System is NHA.

Other records listing Osstem Implant Co., 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 31 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.