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FDA 510(k)

INTEGRA LAMINOPLASTY SYSTEM

K-Number: K130830 · 2013-05-09

ApplicantSeaspine, Inc.
Decision Date2013-05-09
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTEGRA LAMINOPLASTY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Seaspine, Inc.. It received FDA 510(k) clearance on 2013-05-09 under 510(k) number K130830. 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 INTEGRA LAMINOPLASTY SYSTEM?

INTEGRA LAMINOPLASTY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-05-09. The listed applicant is Seaspine, Inc.. The 510(k) number is K130830.

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

INTEGRA LAMINOPLASTY SYSTEM received FDA 510(k) clearance on 2013-05-09, under 510(k) number K130830.

Who is the listed applicant for INTEGRA LAMINOPLASTY SYSTEM?

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

What is the FDA product code for INTEGRA LAMINOPLASTY SYSTEM?

The FDA product code for INTEGRA LAMINOPLASTY SYSTEM is NQW.

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Other records listing Seaspine, 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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