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FDA 510(k)

Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments

K-Number: K153700 · 2016-07-08

ApplicantAesculap Implant Systems, LLC
Decision Date2016-07-08
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments is a medical device manufactured by Aesculap Implant Systems, LLC. It received FDA 510(k) clearance on 2016-07-08 under approval number K153700. 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(R) Implant Systems (AIS) S4 Navigation Instruments?

Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments is a medical device that received FDA 510(k) clearance on 2016-07-08. It is manufactured by Aesculap Implant Systems, LLC. The 510(k) number is K153700.

When was Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments approved by the FDA?

Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments received FDA 510(k) clearance on 2016-07-08, under approval number K153700.

What company makes Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments?

Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments is manufactured by Aesculap Implant Systems, LLC.

What is the FDA product code for Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments?

The FDA product code for Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments is OLO.

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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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