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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2025-06-27 under 510(k) 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. The listed applicant is Jeil Medical Corporation. The 510(k) number is K251431.

When did FIX-C PEEK ACIF SA System receive FDA 510(k) clearance?

FIX-C PEEK ACIF SA System received FDA 510(k) clearance on 2025-06-27, under 510(k) number K251431.

Who is the listed applicant for FIX-C PEEK ACIF SA System?

The FDA 510(k) record lists Jeil Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Jeil Medical Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: OVE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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.

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