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FDA 510(k)

LAMINOPLASTY FIXATION SYSTEM

K-Number: K091623 · 2009-10-09

ApplicantNuvasive, Inc.
Decision Date2009-10-09
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LAMINOPLASTY FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive, Inc.. It received FDA 510(k) clearance on 2009-10-09 under 510(k) number K091623. 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 LAMINOPLASTY FIXATION SYSTEM?

LAMINOPLASTY FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-10-09. The listed applicant is Nuvasive, Inc.. The 510(k) number is K091623.

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

LAMINOPLASTY FIXATION SYSTEM received FDA 510(k) clearance on 2009-10-09, under 510(k) number K091623.

Who is the listed applicant for LAMINOPLASTY FIXATION SYSTEM?

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

What is the FDA product code for LAMINOPLASTY FIXATION SYSTEM?

The FDA product code for LAMINOPLASTY FIXATION SYSTEM is NQW.

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Other records listing Nuvasive, Inc. as applicant

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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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