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FDA 510(k)

EXPANDABLE PEEK VBR IMPLANT

K-Number: K040928 · 2004-08-27

ApplicantInterpore Cross Intl.
Decision Date2004-08-27
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXPANDABLE PEEK VBR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Interpore Cross Intl.. It received FDA 510(k) clearance on 2004-08-27 under 510(k) number K040928. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPANDABLE PEEK VBR IMPLANT?

EXPANDABLE PEEK VBR IMPLANT is a medical device that received FDA 510(k) clearance on 2004-08-27. The listed applicant is Interpore Cross Intl.. The 510(k) number is K040928.

When did EXPANDABLE PEEK VBR IMPLANT receive FDA 510(k) clearance?

EXPANDABLE PEEK VBR IMPLANT received FDA 510(k) clearance on 2004-08-27, under 510(k) number K040928.

Who is the listed applicant for EXPANDABLE PEEK VBR IMPLANT?

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

What is the FDA product code for EXPANDABLE PEEK VBR IMPLANT?

The FDA product code for EXPANDABLE PEEK VBR IMPLANT is MQP.

Related Clinical Trials

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Other records listing Interpore Cross Intl. 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.

K050861PEEK CASK031399INTERGRO DBMK041407TITANIUM MESH IMPLANTK043229MODIFICATION TO ALTIUS OCT SYSTEMK042798C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEMK041794C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM

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Related Devices (Code: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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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