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 a medical device manufactured by Tyber Medical, LLC. It received FDA 510(k) clearance on 2019-01-18 under approval 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. It is manufactured by Tyber Medical, LLC. The 510(k) number is K182284.
When was Tyber Medical PT Interbody Spacer approved by the FDA?
Tyber Medical PT Interbody Spacer received FDA 510(k) clearance on 2019-01-18, under approval number K182284.
What company makes Tyber Medical PT Interbody Spacer?
Tyber Medical PT Interbody Spacer is manufactured by Tyber Medical, LLC.
What is the FDA product code for Tyber Medical PT Interbody Spacer?
The FDA product code for Tyber Medical PT Interbody Spacer is ODP.
Related Clinical Trials
Related PubMed Literature
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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.