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FDA 510(k)

SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)

K-Number: K121548 · 2012-08-16

ApplicantSpine View, Inc.
Decision Date2012-08-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) 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 2012-08-16 under 510(k) number K121548. 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 ENDOSCOPIC SPINE SYSTEM (SESS) is a medical device that received FDA 510(k) clearance on 2012-08-16. The listed applicant is Spine View, Inc.. The 510(k) number is K121548.

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

SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) received FDA 510(k) clearance on 2012-08-16, under 510(k) number K121548.

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

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)?

The FDA product code for SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) 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 CAMERAK120680ENSPIRE DISCECTOMY SYSTEMK113362SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)K110992ENSPIRE DEBRIDER SYSTEM

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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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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