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FDA 510(k)

GRAVILAX TRACTION SYSTEM

K-Number: K072064 · 2008-04-21

Decision Date2008-04-21
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GRAVILAX TRACTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Therapeutic Clinical Technologies, Inc.. It received FDA 510(k) clearance on 2008-04-21 under 510(k) number K072064. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAVILAX TRACTION SYSTEM?

GRAVILAX TRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-21. The listed applicant is Therapeutic Clinical Technologies, Inc.. The 510(k) number is K072064.

When did GRAVILAX TRACTION SYSTEM receive FDA 510(k) clearance?

GRAVILAX TRACTION SYSTEM received FDA 510(k) clearance on 2008-04-21, under 510(k) number K072064.

Who is the listed applicant for GRAVILAX TRACTION SYSTEM?

The FDA 510(k) record lists Therapeutic Clinical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRAVILAX TRACTION SYSTEM?

The FDA product code for GRAVILAX TRACTION SYSTEM is ITH.

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.

Related Devices (Code: ITH)

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.

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