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FDA 510(k)

NUVASIVE COROENT NO-PROFILE SYSTEM

K-Number: K112561 · 2012-03-13

ApplicantNuvasive, Inc.
Decision Date2012-03-13
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NUVASIVE COROENT NO-PROFILE 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 2012-03-13 under 510(k) number K112561. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUVASIVE COROENT NO-PROFILE SYSTEM?

NUVASIVE COROENT NO-PROFILE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-03-13. The listed applicant is Nuvasive, Inc.. The 510(k) number is K112561.

When did NUVASIVE COROENT NO-PROFILE SYSTEM receive FDA 510(k) clearance?

NUVASIVE COROENT NO-PROFILE SYSTEM received FDA 510(k) clearance on 2012-03-13, under 510(k) number K112561.

Who is the listed applicant for NUVASIVE COROENT NO-PROFILE 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 NO-PROFILE SYSTEM?

The FDA product code for NUVASIVE COROENT NO-PROFILE SYSTEM is OVD.

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Other records listing Nuvasive, Inc. as applicant

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Related Devices (Code: OVD)

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.

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA InnovasisK261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.

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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