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FDA 510(k)

SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE

K-Number: K081051 · 2008-08-07

ApplicantSpine View, Inc.
Decision Date2008-08-07
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 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 2008-08-07 under 510(k) number K081051. 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 SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE?

SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE is a medical device that received FDA 510(k) clearance on 2008-08-07. The listed applicant is Spine View, Inc.. The 510(k) number is K081051.

When did SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE receive FDA 510(k) clearance?

SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE received FDA 510(k) clearance on 2008-08-07, under 510(k) number K081051.

Who is the listed applicant for SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE?

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 SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE?

The FDA product code for SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 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)K120680ENSPIRE DISCECTOMY SYSTEMK113362SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)

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Related Devices (Code: HRX)

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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