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FDA 510(k)

coflex-IF

K-Number: K153302 · 2016-09-08

ApplicantParadigm Spine, LLC
Decision Date2016-09-08
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

coflex-IF is the device name listed in this FDA 510(k) record. The listed applicant is Paradigm Spine, LLC. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K153302. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the coflex-IF?

coflex-IF is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is Paradigm Spine, LLC. The 510(k) number is K153302.

When did coflex-IF receive FDA 510(k) clearance?

coflex-IF received FDA 510(k) clearance on 2016-09-08, under 510(k) number K153302.

Who is the listed applicant for coflex-IF?

The FDA 510(k) record lists Paradigm Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for coflex-IF?

The FDA product code for coflex-IF is PEK.

Other records listing Paradigm Spine, LLC 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: PEK)

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.

K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLCK234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3Spinal Simplicity, LLCK233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLCK232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospineK231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.K223790Huvex Interspinous Fusion SystemDio Medical Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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