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FDA 510(k)

Precision Spine Interspinous Plate System

K-Number: K160568 · 2016-05-04

ApplicantPrecision Spine, Inc.
Decision Date2016-05-04
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Precision Spine Interspinous Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Precision Spine, Inc.. It received FDA 510(k) clearance on 2016-05-04 under 510(k) number K160568. 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 Precision Spine Interspinous Plate System?

Precision Spine Interspinous Plate System is a medical device that received FDA 510(k) clearance on 2016-05-04. The listed applicant is Precision Spine, Inc.. The 510(k) number is K160568.

When did Precision Spine Interspinous Plate System receive FDA 510(k) clearance?

Precision Spine Interspinous Plate System received FDA 510(k) clearance on 2016-05-04, under 510(k) number K160568.

Who is the listed applicant for Precision Spine Interspinous Plate System?

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

What is the FDA product code for Precision Spine Interspinous Plate System?

The FDA product code for Precision Spine Interspinous Plate System is PEK.

Other records listing Precision Spine, Inc. as applicant

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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

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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