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FDA 510(k)

THEKEN VU MESH VBR SYSTEM

K-Number: K070381 · 2007-04-25

ApplicantTheken Spine, LLC
Decision Date2007-04-25
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THEKEN VU MESH VBR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Theken Spine, LLC. It received FDA 510(k) clearance on 2007-04-25 under 510(k) number K070381. 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 THEKEN VU MESH VBR SYSTEM?

THEKEN VU MESH VBR SYSTEM is a medical device that received FDA 510(k) clearance on 2007-04-25. The listed applicant is Theken Spine, LLC. The 510(k) number is K070381.

When did THEKEN VU MESH VBR SYSTEM receive FDA 510(k) clearance?

THEKEN VU MESH VBR SYSTEM received FDA 510(k) clearance on 2007-04-25, under 510(k) number K070381.

Who is the listed applicant for THEKEN VU MESH VBR SYSTEM?

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

What is the FDA product code for THEKEN VU MESH VBR SYSTEM?

The FDA product code for THEKEN VU MESH VBR SYSTEM is MQP.

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Other records listing Theken Spine, LLC 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.

K121482INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERYK121211VU APOD INTERVERTEBRAL BODY FUSION DEVICEK120829STAINLESS STEEL SPINAL SYSTEMK120047CORAL SPINAL SYSTEMK111675VU C*POD INTERVERTEBRAL BODY FUSION DEVICEK103228PARAMOUNT R IBF DEVICE

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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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