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FDA 510(k)

S4 SPINAL SYSTEM

K-Number: K050979 · 2005-07-27

ApplicantAesculap, Inc.
Decision Date2005-07-27
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

S4 SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2005-07-27 under 510(k) number K050979. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S4 SPINAL SYSTEM?

S4 SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2005-07-27. The listed applicant is Aesculap, Inc.. The 510(k) number is K050979.

When did S4 SPINAL SYSTEM receive FDA 510(k) clearance?

S4 SPINAL SYSTEM received FDA 510(k) clearance on 2005-07-27, under 510(k) number K050979.

Who is the listed applicant for S4 SPINAL SYSTEM?

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

What is the FDA product code for S4 SPINAL SYSTEM?

The FDA product code for S4 SPINAL SYSTEM is MNI.

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Related Devices (Code: MNI)

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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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