FDA 510(k)

TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF

K-Number: K130573 · 2013-09-30

Decision Date2013-09-30

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF is the device name listed in this FDA 510(k) record. The listed applicant is Tyber Medical, LLC. It received FDA 510(k) clearance on 2013-09-30 under 510(k) number K130573. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF?

TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF is a medical device that received FDA 510(k) clearance on 2013-09-30. The listed applicant is Tyber Medical, LLC. The 510(k) number is K130573.

When did TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF receive FDA 510(k) clearance?

TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF received FDA 510(k) clearance on 2013-09-30, under 510(k) number K130573.

Who is the listed applicant for TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF?

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

What is the FDA product code for TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF?

The FDA product code for TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF is ODP.

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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.