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FDA 510(k)

Aesculap OrthoPilot Next Generation

K-Number: K153396 · 2016-05-16

ApplicantAesculap Implant Systems, LLC
Decision Date2016-05-16
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Aesculap OrthoPilot Next Generation is a medical device manufactured by Aesculap Implant Systems, LLC. It received FDA 510(k) clearance on 2016-05-16 under approval number K153396. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aesculap OrthoPilot Next Generation?

Aesculap OrthoPilot Next Generation is a medical device that received FDA 510(k) clearance on 2016-05-16. It is manufactured by Aesculap Implant Systems, LLC. The 510(k) number is K153396.

When was Aesculap OrthoPilot Next Generation approved by the FDA?

Aesculap OrthoPilot Next Generation received FDA 510(k) clearance on 2016-05-16, under approval number K153396.

What company makes Aesculap OrthoPilot Next Generation?

Aesculap OrthoPilot Next Generation is manufactured by Aesculap Implant Systems, LLC.

What is the FDA product code for Aesculap OrthoPilot Next Generation?

The FDA product code for Aesculap OrthoPilot Next Generation is OLO.

Other Devices by Aesculap Implant Systems, LLC

K162134ENNOVATE Spinal System K153700Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments K180433ENNOVATE® K210963ENNOVATE Spinal System K213871Ennovate Cervical Spinal and Occiput System

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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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