FDA 510(k)

POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM

K-Number: K123549 · 2013-02-25

Decision Date2013-02-25

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Spine (Aka Ebi, LLC). It received FDA 510(k) clearance on 2013-02-25 under 510(k) number K123549. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM?

POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-25. The listed applicant is Biomet Spine (Aka Ebi, LLC). The 510(k) number is K123549.

When did POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM receive FDA 510(k) clearance?

POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM received FDA 510(k) clearance on 2013-02-25, under 510(k) number K123549.

Who is the listed applicant for POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM?

The FDA 510(k) record lists Biomet Spine (Aka Ebi, LLC) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM?

The FDA product code for POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM is NKB.

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Other records listing Biomet Spine (Aka Ebi, LLC) as applicant

K131615POLARIS SPINAL SYSTEM K123451POLARIS SPINAL SYSTEM - BALLISTA II RODS K122989BIOMET LATERAL SPACER SYSTEM K122378NEXTGEN ALTIUS OCT SYSTEM K113593NEXTGEN ALTIUS OCT SYSTEM K110650ZYSTON ARC INTERBODY SPACER

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Related Devices (Code: NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ 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.