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FDA 510(k)

ThermoTK

K-Number: K213256 · 2023-05-25

Decision Date2023-05-25
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ThermoTK is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Medizinsysteme GmbH. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K213256. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ThermoTK?

ThermoTK is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Zimmer Medizinsysteme GmbH. The 510(k) number is K213256.

When did ThermoTK receive FDA 510(k) clearance?

ThermoTK received FDA 510(k) clearance on 2023-05-25, under 510(k) number K213256.

Who is the listed applicant for ThermoTK?

The FDA 510(k) record lists Zimmer Medizinsysteme GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ThermoTK?

The FDA product code for ThermoTK is PBX.

Other records listing Zimmer Medizinsysteme GmbH 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 13 devices →

Related Devices (Code: PBX)

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

View on FDA Database →

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