FDA 510(k)

Modulift Vertebral Body Replacement (VBR) System

K-Nummer: K172032 · 2017-11-20

AntragstellerAesculap Implants Systems, Inc.

Entscheidungsdatum2017-11-20

ProduktcodePLR

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Verwandte Geräte (Code: PLR)

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.

Offizielle Quelle

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