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FDA 510(k)

AFFIX II SPINOUS PROCESS PLATE SYSTEM

K-Number: K132411 · 2013-11-20

ApplicantNu Vasive, Incorporated
Decision Date2013-11-20
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AFFIX II SPINOUS PROCESS PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2013-11-20 under 510(k) number K132411. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFFIX II SPINOUS PROCESS PLATE SYSTEM?

AFFIX II SPINOUS PROCESS PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-20. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K132411.

When did AFFIX II SPINOUS PROCESS PLATE SYSTEM receive FDA 510(k) clearance?

AFFIX II SPINOUS PROCESS PLATE SYSTEM received FDA 510(k) clearance on 2013-11-20, under 510(k) number K132411.

Who is the listed applicant for AFFIX II SPINOUS PROCESS PLATE SYSTEM?

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

What is the FDA product code for AFFIX II SPINOUS PROCESS PLATE SYSTEM?

The FDA product code for AFFIX II SPINOUS PROCESS PLATE SYSTEM is PEK.

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Other records listing Nu Vasive, Incorporated 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.

K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody SystemK230894NuVasive Modulus ALIF SystemK230989Rod Registration FrameK223181NuVasive Reline SystemK221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceK221388NuVasive Reline Cervical System

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Related Devices (Code: PEK)

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.

K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLCK234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3Spinal Simplicity, LLCK233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLCK232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospineK231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.K223790Huvex Interspinous Fusion SystemDio Medical Corp.

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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