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FDA 510(k)

TM-400 DEVICE

K-Number: K120203 · 2012-06-15

ApplicantZimmer Trabecular Metal Technology, Inc.
Decision Date2012-06-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TM-400 DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Trabecular Metal Technology, Inc.. It received FDA 510(k) clearance on 2012-06-15 under 510(k) number K120203. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TM-400 DEVICE?

TM-400 DEVICE is a medical device that received FDA 510(k) clearance on 2012-06-15. The listed applicant is Zimmer Trabecular Metal Technology, Inc.. The 510(k) number is K120203.

When did TM-400 DEVICE receive FDA 510(k) clearance?

TM-400 DEVICE received FDA 510(k) clearance on 2012-06-15, under 510(k) number K120203.

Who is the listed applicant for TM-400 DEVICE?

The FDA 510(k) record lists Zimmer Trabecular Metal Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TM-400 DEVICE?

The FDA product code for TM-400 DEVICE is MAX.

Related Clinical Trials

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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Other records listing Zimmer Trabecular Metal Technology, Inc. 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.

K103517TRABECULAR METAL FEMORAL CONE AUGMENTS

Related Devices (Code: MAX)

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

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

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