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FDA 510(k)

GALLERY LAMINOPLASTY FIXATION SYSTEM

K-Number: K100805 · 2010-07-20

ApplicantBiomet Spine (Aka Ebi, LLC)
Decision Date2010-07-20
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GALLERY LAMINOPLASTY FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Spine (Aka Ebi, LLC). It received FDA 510(k) clearance on 2010-07-20 under 510(k) number K100805. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALLERY LAMINOPLASTY FIXATION SYSTEM?

GALLERY LAMINOPLASTY FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-07-20. The listed applicant is Biomet Spine (Aka Ebi, LLC). The 510(k) number is K100805.

When did GALLERY LAMINOPLASTY FIXATION SYSTEM receive FDA 510(k) clearance?

GALLERY LAMINOPLASTY FIXATION SYSTEM received FDA 510(k) clearance on 2010-07-20, under 510(k) number K100805.

Who is the listed applicant for GALLERY LAMINOPLASTY FIXATION SYSTEM?

The FDA 510(k) record lists Biomet Spine (Aka Ebi, LLC) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GALLERY LAMINOPLASTY FIXATION SYSTEM?

The FDA product code for GALLERY LAMINOPLASTY FIXATION SYSTEM is NQW.

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Other records listing Biomet Spine (Aka Ebi, LLC) as applicant

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K131615POLARIS SPINAL SYSTEMK123549POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEMK123451POLARIS SPINAL SYSTEM - BALLISTA II RODSK122989BIOMET LATERAL SPACER SYSTEMK122378NEXTGEN ALTIUS OCT SYSTEMK113593NEXTGEN ALTIUS OCT SYSTEM

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Related Devices (Code: NQW)

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.

K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd.K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc.K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLCK232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLCK231232Curiteva Laminoplasty SystemCuriteva, Inc.K212428Centerpiece Plate Fixation SystemMedtronic Sofamor Danek

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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