FDA 510(k)

TENO FIX

K-Number: K023594 · 2003-05-15

Decision Date2003-05-15

Product CodeGAQ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

TENO FIX is the device name listed in this FDA 510(k) record. The listed applicant is Ortheon Medical, LLC. It received FDA 510(k) clearance on 2003-05-15 under 510(k) number K023594. The device is classified under product code GAQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENO FIX?

TENO FIX is a medical device that received FDA 510(k) clearance on 2003-05-15. The listed applicant is Ortheon Medical, LLC. The 510(k) number is K023594.

When did TENO FIX receive FDA 510(k) clearance?

TENO FIX received FDA 510(k) clearance on 2003-05-15, under 510(k) number K023594.

Who is the listed applicant for TENO FIX?

The FDA 510(k) record lists Ortheon Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENO FIX?

The FDA product code for TENO FIX is GAQ.

Related Devices (Code: GAQ)

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.