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FDA 510(k)

NUVASIVE COROENT SYSTEM

K-Number: K081611 · 2008-10-02

ApplicantNuvasive, Inc.
Decision Date2008-10-02
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NUVASIVE COROENT 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 2008-10-02 under 510(k) number K081611. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUVASIVE COROENT SYSTEM?

NUVASIVE COROENT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-02. The listed applicant is Nuvasive, Inc.. The 510(k) number is K081611.

When did NUVASIVE COROENT SYSTEM receive FDA 510(k) clearance?

NUVASIVE COROENT SYSTEM received FDA 510(k) clearance on 2008-10-02, under 510(k) number K081611.

Who is the listed applicant for NUVASIVE COROENT 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 COROENT SYSTEM?

The FDA product code for NUVASIVE COROENT SYSTEM is ODP.

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Other records listing Nuvasive, 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.

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: ODP)

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.

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

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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