FIX-C PEEK ACIF SA System
K-Number: K251431 · 2025-06-27
ApplicantJeil Medical Corporation
Decision Date2025-06-27
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
FIX-C PEEK ACIF SA System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2025-06-27 under approval number K251431. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FIX-C PEEK ACIF SA System?
FIX-C PEEK ACIF SA System is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by Jeil Medical Corporation. The 510(k) number is K251431.
When was FIX-C PEEK ACIF SA System approved by the FDA?
FIX-C PEEK ACIF SA System received FDA 510(k) clearance on 2025-06-27, under approval number K251431.
What company makes FIX-C PEEK ACIF SA System?
FIX-C PEEK ACIF SA System is manufactured by Jeil Medical Corporation.
What is the FDA product code for FIX-C PEEK ACIF SA System?
The FDA product code for FIX-C PEEK ACIF SA System is OVE.
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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.