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FDA 510(k)

PATHWAY AVID

K-Number: K090566 · 2009-06-01

ApplicantCustom Spine, Inc.
Decision Date2009-06-01
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PATHWAY AVID is the device name listed in this FDA 510(k) record. The listed applicant is Custom Spine, Inc.. It received FDA 510(k) clearance on 2009-06-01 under 510(k) number K090566. 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 PATHWAY AVID?

PATHWAY AVID is a medical device that received FDA 510(k) clearance on 2009-06-01. The listed applicant is Custom Spine, Inc.. The 510(k) number is K090566.

When did PATHWAY AVID receive FDA 510(k) clearance?

PATHWAY AVID received FDA 510(k) clearance on 2009-06-01, under 510(k) number K090566.

Who is the listed applicant for PATHWAY AVID?

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

What is the FDA product code for PATHWAY AVID?

The FDA product code for PATHWAY AVID is MAX.

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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 Custom Spine, Inc. 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.

K120597KOMPREDAK111726PATHWAY AVIDK111099ISSYS LP SPINAL FIXATION SYSTEMK092904PATHWAY IVB/VBRK091134CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATEK080281PATHWAY

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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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