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FDA 510(k)

CASPIAN SPINAL SYSTEM

K-Number: K092640 · 2009-11-06

ApplicantK2m, Inc.
Decision Date2009-11-06
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CASPIAN SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2009-11-06 under 510(k) number K092640. 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 CASPIAN SPINAL SYSTEM?

CASPIAN SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2009-11-06. The listed applicant is K2m, Inc.. The 510(k) number is K092640.

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

CASPIAN SPINAL SYSTEM received FDA 510(k) clearance on 2009-11-06, under 510(k) number K092640.

Who is the listed applicant for CASPIAN SPINAL SYSTEM?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CASPIAN SPINAL SYSTEM?

The FDA product code for CASPIAN 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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