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FDA 510(k)

Tyber Medical PT Interbody Spacer

K-Number: K182284 · 2019-01-18

ApplicantTyber Medical, LLC
Decision Date2019-01-18
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tyber Medical PT Interbody Spacer 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 2019-01-18 under 510(k) number K182284. 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 PT Interbody Spacer?

Tyber Medical PT Interbody Spacer is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is Tyber Medical, LLC. The 510(k) number is K182284.

When did Tyber Medical PT Interbody Spacer receive FDA 510(k) clearance?

Tyber Medical PT Interbody Spacer received FDA 510(k) clearance on 2019-01-18, under 510(k) number K182284.

Who is the listed applicant for Tyber Medical PT Interbody Spacer?

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 PT Interbody Spacer?

The FDA product code for Tyber Medical PT Interbody Spacer 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.

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