FDA 510(k)

TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION

K-Number: K113561 · 2012-05-29

ApplicantZimmer Trabecular Metal Technology

Decision Date2012-05-29

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Trabecular Metal Technology. It received FDA 510(k) clearance on 2012-05-29 under 510(k) number K113561. 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 TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION?

TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION is a medical device that received FDA 510(k) clearance on 2012-05-29. The listed applicant is Zimmer Trabecular Metal Technology. The 510(k) number is K113561.

When did TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION receive FDA 510(k) clearance?

TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION received FDA 510(k) clearance on 2012-05-29, under 510(k) number K113561.

Who is the listed applicant for TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION?

The FDA 510(k) record lists Zimmer Trabecular Metal Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION?

The FDA product code for TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION is MAX.

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Other records listing Zimmer Trabecular Metal Technology as applicant

K123602TM ARDIS INTERBODY SYSTEM INSERTER K120990NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL K111983VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX K103033TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX K102896TRABECULAR METAL TIBIAL CONE AUGMENTS K093127TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET

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Related Devices (Code: MAX)

K261049SCALA® TLSpineart SA K261430TruLift 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 Corporation K253151Fule 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.