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FDA 510(k)

NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM

K-Number: K002677 · 2000-11-13

ApplicantNuvasive, Inc.
Decision Date2000-11-13
Product CodeBXM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE 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 2000-11-13 under 510(k) number K002677. The device is classified under product code BXM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM?

NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM is a medical device that received FDA 510(k) clearance on 2000-11-13. The listed applicant is Nuvasive, Inc.. The 510(k) number is K002677.

When did NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM receive FDA 510(k) clearance?

NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM received FDA 510(k) clearance on 2000-11-13, under 510(k) number K002677.

Who is the listed applicant for NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE 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 INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM?

The FDA product code for NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM is BXM.

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Other records listing Nuvasive, Inc. as applicant

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K240507NuVasive AttraX ScaffoldK223731NuVasive Modulus-C Interbody SystemK211757Simplify DiscK173117NuVasive® VersaTie™ SystemK133052AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEMK131025ARCHON ANTERIOR CERVICAL PLATE SYSTEM

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Related Devices (Code: BXM)

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.

K013215MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEMNuvasive, Inc.K921498VER MED A10011 PNS DUAL ELEMENT ELECTRODEVermont Medical, Inc.K870662MODEL SKCK STERILE KNOB COVER KITLife-Tech Intl., Inc.

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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