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FDA 510(k)

S4C NAVIGATION INSTRUMENTS

K-Number: K130887 · 2013-08-13

ApplicantAesculap Implant System, Inc.
Decision Date2013-08-13
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

S4C NAVIGATION INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant System, Inc.. It received FDA 510(k) clearance on 2013-08-13 under 510(k) number K130887. 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 S4C NAVIGATION INSTRUMENTS?

S4C NAVIGATION INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2013-08-13. The listed applicant is Aesculap Implant System, Inc.. The 510(k) number is K130887.

When did S4C NAVIGATION INSTRUMENTS receive FDA 510(k) clearance?

S4C NAVIGATION INSTRUMENTS received FDA 510(k) clearance on 2013-08-13, under 510(k) number K130887.

Who is the listed applicant for S4C NAVIGATION INSTRUMENTS?

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

What is the FDA product code for S4C NAVIGATION INSTRUMENTS?

The FDA product code for S4C NAVIGATION INSTRUMENTS is OLO.

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Other records listing Aesculap Implant System, Inc. as applicant

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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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