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FDA 510(k)

NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM

K-Number: K990324 · 1999-10-05

ApplicantNuvasive, Inc.
Decision Date1999-10-05
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive, Inc.. It received FDA 510(k) clearance on 1999-10-05 under 510(k) number K990324. 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 NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM?

NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM is a medical device that received FDA 510(k) clearance on 1999-10-05. The listed applicant is Nuvasive, Inc.. The 510(k) number is K990324.

When did NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM receive FDA 510(k) clearance?

NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM received FDA 510(k) clearance on 1999-10-05, under 510(k) number K990324.

Who is the listed applicant for NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM?

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

What is the FDA product code for NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM?

The FDA product code for NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM is HRX.

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Related Devices (Code: HRX)

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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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