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FDA 510(k)

SPECTRUM SPINE SPINOUS PROCESS DEVICE

K-Number: K130066 · 2013-11-12

ApplicantSpectrum Spine IP Holdings, LLC
Decision Date2013-11-12
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPECTRUM SPINE SPINOUS PROCESS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Spine IP Holdings, LLC. It received FDA 510(k) clearance on 2013-11-12 under 510(k) number K130066. 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 SPECTRUM SPINE SPINOUS PROCESS DEVICE?

SPECTRUM SPINE SPINOUS PROCESS DEVICE is a medical device that received FDA 510(k) clearance on 2013-11-12. The listed applicant is Spectrum Spine IP Holdings, LLC. The 510(k) number is K130066.

When did SPECTRUM SPINE SPINOUS PROCESS DEVICE receive FDA 510(k) clearance?

SPECTRUM SPINE SPINOUS PROCESS DEVICE received FDA 510(k) clearance on 2013-11-12, under 510(k) number K130066.

Who is the listed applicant for SPECTRUM SPINE SPINOUS PROCESS DEVICE?

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

What is the FDA product code for SPECTRUM SPINE SPINOUS PROCESS DEVICE?

The FDA product code for SPECTRUM SPINE SPINOUS PROCESS DEVICE is PEK.

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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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