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FDA 510(k)

Modulift Vertebral Body Replacement (VBR) System

K-Number: K172032 · 2017-11-20

ApplicantAesculap Implants Systems, Inc.
Decision Date2017-11-20
Product CodePLR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Modulift Vertebral Body Replacement (VBR) System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implants Systems, Inc.. It received FDA 510(k) clearance on 2017-11-20 under 510(k) number K172032. 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 Modulift Vertebral Body Replacement (VBR) System?

Modulift Vertebral Body Replacement (VBR) System is a medical device that received FDA 510(k) clearance on 2017-11-20. The listed applicant is Aesculap Implants Systems, Inc.. The 510(k) number is K172032.

When did Modulift Vertebral Body Replacement (VBR) System receive FDA 510(k) clearance?

Modulift Vertebral Body Replacement (VBR) System received FDA 510(k) clearance on 2017-11-20, under 510(k) number K172032.

Who is the listed applicant for Modulift Vertebral Body Replacement (VBR) System?

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

What is the FDA product code for Modulift Vertebral Body Replacement (VBR) System?

The FDA product code for Modulift Vertebral Body Replacement (VBR) System is PLR.

Related PubMed Literature

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.

PMID: 38273730Ten-Year Risk of Recall of Novel Spine Devices.Spine (2024)

Other records listing Aesculap Implants Systems, Inc. as applicant

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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, LLCK221542Galileo Vertebral Body Replacement DeviceBright SpineK212126MediExpand 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.

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