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FDA 510(k)

XIPHOS

K-Number: K123969 · 2013-02-07

ApplicantDifusion Technologies
Decision Date2013-02-07
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

XIPHOS is the device name listed in this FDA 510(k) record. The listed applicant is Difusion Technologies. It received FDA 510(k) clearance on 2013-02-07 under 510(k) number K123969. 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 XIPHOS?

XIPHOS is a medical device that received FDA 510(k) clearance on 2013-02-07. The listed applicant is Difusion Technologies. The 510(k) number is K123969.

When did XIPHOS receive FDA 510(k) clearance?

XIPHOS received FDA 510(k) clearance on 2013-02-07, under 510(k) number K123969.

Who is the listed applicant for XIPHOS?

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

What is the FDA product code for XIPHOS?

The FDA product code for XIPHOS is MAX.

Related Clinical Trials

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.

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Other records listing Difusion Technologies 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.

K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemK100042DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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