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FDA 510(k)

VU C*POD INTERVERTEBRAL BODY FUSION DEVICE

K-Number: K111675 · 2011-08-02

ApplicantTheken Spine, LLC
Decision Date2011-08-02
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VU C*POD INTERVERTEBRAL BODY FUSION DEVICE 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 2011-08-02 under 510(k) number K111675. 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 VU C*POD INTERVERTEBRAL BODY FUSION DEVICE?

VU C*POD INTERVERTEBRAL BODY FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2011-08-02. The listed applicant is Theken Spine, LLC. The 510(k) number is K111675.

When did VU C*POD INTERVERTEBRAL BODY FUSION DEVICE receive FDA 510(k) clearance?

VU C*POD INTERVERTEBRAL BODY FUSION DEVICE received FDA 510(k) clearance on 2011-08-02, under 510(k) number K111675.

Who is the listed applicant for VU C*POD INTERVERTEBRAL BODY FUSION DEVICE?

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 VU C*POD INTERVERTEBRAL BODY FUSION DEVICE?

The FDA product code for VU C*POD INTERVERTEBRAL BODY FUSION DEVICE is ODP.

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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 SYSTEMK103228PARAMOUNT R IBF DEVICEK102323CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE

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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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