MectaLIF Transforaminal TiPEEK
K-Number: K200551 · 2021-02-12
ApplicantMedacta Inernational SA
Decision Date2021-02-12
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MectaLIF Transforaminal TiPEEK is a medical device manufactured by Medacta Inernational SA. It received FDA 510(k) clearance on 2021-02-12 under approval number K200551. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MectaLIF Transforaminal TiPEEK?
MectaLIF Transforaminal TiPEEK is a medical device that received FDA 510(k) clearance on 2021-02-12. It is manufactured by Medacta Inernational SA. The 510(k) number is K200551.
When was MectaLIF Transforaminal TiPEEK approved by the FDA?
MectaLIF Transforaminal TiPEEK received FDA 510(k) clearance on 2021-02-12, under approval number K200551.
What company makes MectaLIF Transforaminal TiPEEK?
MectaLIF Transforaminal TiPEEK is manufactured by Medacta Inernational SA.
What is the FDA product code for MectaLIF Transforaminal TiPEEK?
The FDA product code for MectaLIF Transforaminal TiPEEK is MAX.
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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.