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FDA 510(k)

primaLOK™ SP Interspinous Fusion System

K-Number: K231807 · 2023-08-15

ApplicantWenzel Spine, Inc.
Decision Date2023-08-15
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

primaLOK™ SP Interspinous Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Wenzel Spine, Inc.. It received FDA 510(k) clearance on 2023-08-15 under 510(k) number K231807. 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 primaLOK™ SP Interspinous Fusion System?

primaLOK™ SP Interspinous Fusion System is a medical device that received FDA 510(k) clearance on 2023-08-15. The listed applicant is Wenzel Spine, Inc.. The 510(k) number is K231807.

When did primaLOK™ SP Interspinous Fusion System receive FDA 510(k) clearance?

primaLOK™ SP Interspinous Fusion System received FDA 510(k) clearance on 2023-08-15, under 510(k) number K231807.

Who is the listed applicant for primaLOK™ SP Interspinous Fusion System?

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

What is the FDA product code for primaLOK™ SP Interspinous Fusion System?

The FDA product code for primaLOK™ SP Interspinous Fusion System is PEK.

Other records listing Wenzel Spine, Inc. 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.

K250247panaSIa SI Fusion SystemK231076VariLift®-C Interbody Fusion SystemK180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System

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 SystemFlospineK223790Huvex Interspinous Fusion SystemDio Medical Corp.K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5Spinal Simplicity, LLC

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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