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FDA 510(k)

PATHWAY IVB/VBR

K-Number: K092904 · 2009-12-22

ApplicantCustom Spine, Inc.
Decision Date2009-12-22
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PATHWAY IVB/VBR 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 2009-12-22 under 510(k) number K092904. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHWAY IVB/VBR?

PATHWAY IVB/VBR is a medical device that received FDA 510(k) clearance on 2009-12-22. The listed applicant is Custom Spine, Inc.. The 510(k) number is K092904.

When did PATHWAY IVB/VBR receive FDA 510(k) clearance?

PATHWAY IVB/VBR received FDA 510(k) clearance on 2009-12-22, under 510(k) number K092904.

Who is the listed applicant for PATHWAY IVB/VBR?

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 IVB/VBR?

The FDA product code for PATHWAY IVB/VBR is ODP.

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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 SYSTEMK091134CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATEK090566PATHWAY AVIDK080281PATHWAY

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Related Devices (Code: ODP)

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.

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED 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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