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FDA 510(k)

VBR

K-Number: K012254 · 2001-10-16

ApplicantOsteotech, Inc.
Decision Date2001-10-16
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VBR is the device name listed in this FDA 510(k) record. The listed applicant is Osteotech, Inc.. It received FDA 510(k) clearance on 2001-10-16 under 510(k) number K012254. 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 VBR?

VBR is a medical device that received FDA 510(k) clearance on 2001-10-16. The listed applicant is Osteotech, Inc.. The 510(k) number is K012254.

When did VBR receive FDA 510(k) clearance?

VBR received FDA 510(k) clearance on 2001-10-16, under 510(k) number K012254.

Who is the listed applicant for VBR?

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

What is the FDA product code for VBR?

The FDA product code for VBR is MQP.

Other records listing Osteotech, 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.

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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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