FIX-L PEEK PLIF and T-PLIF System
K-Number: K243973 · 2025-06-12
ApplicantJeil Medical Corporation
Decision Date2025-06-12
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
FIX-L PEEK PLIF and T-PLIF System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2025-06-12 under approval number K243973. 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 FIX-L PEEK PLIF and T-PLIF System?
FIX-L PEEK PLIF and T-PLIF System is a medical device that received FDA 510(k) clearance on 2025-06-12. It is manufactured by Jeil Medical Corporation. The 510(k) number is K243973.
When was FIX-L PEEK PLIF and T-PLIF System approved by the FDA?
FIX-L PEEK PLIF and T-PLIF System received FDA 510(k) clearance on 2025-06-12, under approval number K243973.
What company makes FIX-L PEEK PLIF and T-PLIF System?
FIX-L PEEK PLIF and T-PLIF System is manufactured by Jeil Medical Corporation.
What is the FDA product code for FIX-L PEEK PLIF and T-PLIF System?
The FDA product code for FIX-L PEEK PLIF and T-PLIF System 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.