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FDA 510(k)

PEEK CAS

K-Number: K050861 · 2005-05-27

ApplicantInterpore Cross Intl.
Decision Date2005-05-27
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PEEK CAS 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 2005-05-27 under 510(k) number K050861. 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 PEEK CAS?

PEEK CAS is a medical device that received FDA 510(k) clearance on 2005-05-27. The listed applicant is Interpore Cross Intl.. The 510(k) number is K050861.

When did PEEK CAS receive FDA 510(k) clearance?

PEEK CAS received FDA 510(k) clearance on 2005-05-27, under 510(k) number K050861.

Who is the listed applicant for PEEK CAS?

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 PEEK CAS?

The FDA product code for PEEK CAS is MQP.

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.

K031399INTERGRO DBMK041407TITANIUM MESH IMPLANTK043229MODIFICATION TO ALTIUS OCT SYSTEMK042798C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEMK040928EXPANDABLE PEEK VBR IMPLANTK041794C-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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