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FDA 510(k)

ENSPIRE DISCECTOMY SYSTEM

K-Number: K120680 · 2012-06-26

ApplicantSpine View, Inc.
Decision Date2012-06-26
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENSPIRE DISCECTOMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spine View, Inc.. It received FDA 510(k) clearance on 2012-06-26 under 510(k) number K120680. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENSPIRE DISCECTOMY SYSTEM?

ENSPIRE DISCECTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-26. The listed applicant is Spine View, Inc.. The 510(k) number is K120680.

When did ENSPIRE DISCECTOMY SYSTEM receive FDA 510(k) clearance?

ENSPIRE DISCECTOMY SYSTEM received FDA 510(k) clearance on 2012-06-26, under 510(k) number K120680.

Who is the listed applicant for ENSPIRE DISCECTOMY SYSTEM?

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

What is the FDA product code for ENSPIRE DISCECTOMY SYSTEM?

The FDA product code for ENSPIRE DISCECTOMY SYSTEM is HRX.

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Other records listing Spine View, Inc. as applicant

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.

K160856SpineView X-Pac Expandable Lumbar Cage SystemK152539SpineView X-Pac Expandable Lumbar Cage SystemK122134FLEXLITE CAMERAK121548SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)K113362SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)K110992ENSPIRE DEBRIDER SYSTEM

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Related Devices (Code: HRX)

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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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