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FDA 510(k)

ZAVATION IBF SYSTEM

K-Number: K120576 · 2012-03-28

ApplicantZavation, LLC
Decision Date2012-03-28
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZAVATION IBF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zavation, LLC. It received FDA 510(k) clearance on 2012-03-28 under 510(k) number K120576. 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 ZAVATION IBF SYSTEM?

ZAVATION IBF SYSTEM is a medical device that received FDA 510(k) clearance on 2012-03-28. The listed applicant is Zavation, LLC. The 510(k) number is K120576.

When did ZAVATION IBF SYSTEM receive FDA 510(k) clearance?

ZAVATION IBF SYSTEM received FDA 510(k) clearance on 2012-03-28, under 510(k) number K120576.

Who is the listed applicant for ZAVATION IBF SYSTEM?

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

What is the FDA product code for ZAVATION IBF SYSTEM?

The FDA product code for ZAVATION IBF SYSTEM is MAX.

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Other records listing Zavation, 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.

K162206Zavation IBFK162575Z-LINKPC SystemK162824Z-Span Plate SystemK161016Z-Clamp ISP SystemK153404Zavation Spinal SystemK160362Z-Span Plate 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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