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FDA 510(k)

SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System

K-Number: K180156 · 2018-03-07

ApplicantGlobus Medical, Inc.
Decision Date2018-03-07
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2018-03-07 under approval number K180156. 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 SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System?

SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System is a medical device that received FDA 510(k) clearance on 2018-03-07. It is manufactured by Globus Medical, Inc.. The 510(k) number is K180156.

When was SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System approved by the FDA?

SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System received FDA 510(k) clearance on 2018-03-07, under approval number K180156.

What company makes SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System?

SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System is manufactured by Globus Medical, Inc..

What is the FDA product code for SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System?

The FDA product code for SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System is PEK.

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Related PubMed Literature

PMID: 39382899 US FDA Advisory Panel Members' Assessment of Premarket Approval Process and Suggestions for Improvement. JAMA network open (2024) PMID: 38815918 What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices. Annals of vascular surgery (2024) PMID: 37365092 Comparison of the international regulations for medical devices-USA versus Europe. Injury (2023) PMID: 35964220 Post-market surveillance of medical devices: A review. Technology and health care : official journal of the European Society for Engineering and Medicine (2022)

Other Devices by Globus Medical, Inc.

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Related Devices (Code: PEK)

K161016Z-Clamp ISP SystemZavation, LLC K153302coflex-IFParadigm Spine, LLC K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc. K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC K162849Huvex Interspinous Fixation SystemDio Medical Co., Ltd.

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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