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FDA 510(k)

SOCON SPINAL SYSTEM

K-Number: K993551 · 2000-01-13

ApplicantAesculap, Inc.
Decision Date2000-01-13
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOCON 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 2000-01-13 under 510(k) number K993551. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOCON SPINAL SYSTEM?

SOCON SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2000-01-13. The listed applicant is Aesculap, Inc.. The 510(k) number is K993551.

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

SOCON SPINAL SYSTEM received FDA 510(k) clearance on 2000-01-13, under 510(k) number K993551.

Who is the listed applicant for SOCON 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 SOCON SPINAL SYSTEM?

The FDA product code for SOCON SPINAL SYSTEM is MNH. This falls under the ENT category.

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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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