AIS MODULIFT VBR SYSTEM— 510(k) K133802

Name: FDA 510(k) clearance K133802
Creator: U.S. Food and Drug Administration
Published: 2014-04-17

Substantially Equivalent

Aesculap Implant System, Inc.

FDA 510(k) clearance K133802 for AIS MODULIFT VBR SYSTEM, Substantially Equivalent on 2014-04-17. Applicant: Aesculap Implant System, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap Implant System, Inc.
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2013-12-13
Decision date: 2014-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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K232790 — KONG®-TL VBR System and KONG® C VBR System2024-04-04

More clearances from Aesculap Implant System, Inc.

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K142707 — AIS Odontoid Fracture Fixation System2014-12-19
K142150 — AIS MODULIFT VBR SYSTEM2014-10-29
K122783 — PLASMAFIT ACETABULAR CUP AND VITELENE INSERT2013-10-30
K130887 — S4C NAVIGATION INSTRUMENTS2013-08-13
K123909 — AESCULAP CESPACE XP2013-04-15

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.