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FDA 510(k)

RELIEVE LAMINOPLASTY FIXATION SYSTEM

K-Number: K080664 · 2008-07-25

ApplicantGlobus Medical, Inc.
Decision Date2008-07-25
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RELIEVE LAMINOPLASTY FIXATION SYSTEM 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 2008-07-25 under 510(k) number K080664. 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 RELIEVE LAMINOPLASTY FIXATION SYSTEM?

RELIEVE LAMINOPLASTY FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-25. The listed applicant is Globus Medical, Inc.. The 510(k) number is K080664.

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

RELIEVE LAMINOPLASTY FIXATION SYSTEM received FDA 510(k) clearance on 2008-07-25, under 510(k) number K080664.

Who is the listed applicant for RELIEVE LAMINOPLASTY FIXATION SYSTEM?

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 RELIEVE LAMINOPLASTY FIXATION SYSTEM?

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

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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.

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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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