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FDA 510(k)

VU APOD INTERVERTEBRAL BODY FUSION DEVICE

K-Number: K101310 · 2010-09-02

ApplicantTheken Spine, LLC
Decision Date2010-09-02
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VU APOD 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 2010-09-02 under 510(k) number K101310. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VU APOD INTERVERTEBRAL BODY FUSION DEVICE?

VU APOD INTERVERTEBRAL BODY FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2010-09-02. The listed applicant is Theken Spine, LLC. The 510(k) number is K101310.

When did VU APOD INTERVERTEBRAL BODY FUSION DEVICE receive FDA 510(k) clearance?

VU APOD INTERVERTEBRAL BODY FUSION DEVICE received FDA 510(k) clearance on 2010-09-02, under 510(k) number K101310.

Who is the listed applicant for VU APOD 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 APOD INTERVERTEBRAL BODY FUSION DEVICE?

The FDA product code for VU APOD INTERVERTEBRAL BODY FUSION DEVICE is OVD.

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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: OVD)

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.

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA InnovasisK261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.

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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