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FDA 510(k)

SP-FIX SPINOUS PROCESS FIXATION PLATE

K-Number: K132191 · 2013-11-22

ApplicantGlobus Medical, Inc.
Decision Date2013-11-22
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SP-FIX SPINOUS PROCESS FIXATION PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2013-11-22 under 510(k) number K132191. 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?

SP-FIX SPINOUS PROCESS FIXATION PLATE is a medical device that received FDA 510(k) clearance on 2013-11-22. The listed applicant is Globus Medical, Inc.. The 510(k) number is K132191.

When did SP-FIX SPINOUS PROCESS FIXATION PLATE receive FDA 510(k) clearance?

SP-FIX SPINOUS PROCESS FIXATION PLATE received FDA 510(k) clearance on 2013-11-22, under 510(k) number K132191.

Who is the listed applicant for SP-FIX SPINOUS PROCESS FIXATION PLATE?

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

What is the FDA product code for SP-FIX SPINOUS PROCESS FIXATION PLATE?

The FDA product code for SP-FIX SPINOUS PROCESS FIXATION PLATE 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

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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