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FDA 510(k)

ZYSTON ARC INTERBODY SPACER

K-Number: K110650 · 2011-06-30

ApplicantBiomet Spine (Aka Ebi, LLC)
Decision Date2011-06-30
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZYSTON ARC INTERBODY SPACER 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 2011-06-30 under 510(k) number K110650. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZYSTON ARC INTERBODY SPACER?

ZYSTON ARC INTERBODY SPACER is a medical device that received FDA 510(k) clearance on 2011-06-30. The listed applicant is Biomet Spine (Aka Ebi, LLC). The 510(k) number is K110650.

When did ZYSTON ARC INTERBODY SPACER receive FDA 510(k) clearance?

ZYSTON ARC INTERBODY SPACER received FDA 510(k) clearance on 2011-06-30, under 510(k) number K110650.

Who is the listed applicant for ZYSTON ARC INTERBODY SPACER?

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 ZYSTON ARC INTERBODY SPACER?

The FDA product code for ZYSTON ARC INTERBODY SPACER is MAX.

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Other records listing Biomet Spine (Aka Ebi, LLC) 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.

K131615POLARIS SPINAL SYSTEMK123549POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEMK123451POLARIS SPINAL SYSTEM - BALLISTA II RODSK122989BIOMET LATERAL SPACER SYSTEMK122378NEXTGEN ALTIUS OCT SYSTEMK113593NEXTGEN ALTIUS OCT SYSTEM

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Related Devices (Code: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development 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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