FDA 510(k)

C-VBR

K-Number: K152568 · 2016-02-11

Decision Date2016-02-11

Product CodePLR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

C-VBR is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Spine, LLC. It received FDA 510(k) clearance on 2016-02-11 under 510(k) number K152568. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-VBR?

C-VBR is a medical device that received FDA 510(k) clearance on 2016-02-11. The listed applicant is Cardinal Spine, LLC. The 510(k) number is K152568.

When did C-VBR receive FDA 510(k) clearance?

C-VBR received FDA 510(k) clearance on 2016-02-11, under 510(k) number K152568.

Who is the listed applicant for C-VBR?

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

What is the FDA product code for C-VBR?

The FDA product code for C-VBR is PLR.

Related Devices (Code: PLR)

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.

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc.K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemAtlas Spine, Inc.K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC K221542Galileo Vertebral Body Replacement DeviceBright Spine K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.K211320CAPRI Corpectomy Cage SystemK2m, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.