Tyber Medical PT Interbody Spacer System
K-Number: K172185 · 2017-12-21
ApplicantTyber Medical, LLC
Decision Date2017-12-21
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Tyber Medical PT Interbody Spacer System is a medical device manufactured by Tyber Medical, LLC. It received FDA 510(k) clearance on 2017-12-21 under approval number K172185. 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 System?
Tyber Medical PT Interbody Spacer System is a medical device that received FDA 510(k) clearance on 2017-12-21. It is manufactured by Tyber Medical, LLC. The 510(k) number is K172185.
When was Tyber Medical PT Interbody Spacer System approved by the FDA?
Tyber Medical PT Interbody Spacer System received FDA 510(k) clearance on 2017-12-21, under approval number K172185.
What company makes Tyber Medical PT Interbody Spacer System?
Tyber Medical PT Interbody Spacer System is manufactured by Tyber Medical, LLC.
What is the FDA product code for Tyber Medical PT Interbody Spacer System?
The FDA product code for Tyber Medical PT Interbody Spacer System 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.