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FDA 510(k)

SANTORINI SPINAL SYSTEM

K-Number: K111294 · 2012-01-27

ApplicantK2m, Inc.
Decision Date2012-01-27
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SANTORINI 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 2012-01-27 under 510(k) number K111294. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANTORINI SPINAL SYSTEM?

SANTORINI SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-27. The listed applicant is K2m, Inc.. The 510(k) number is K111294.

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

SANTORINI SPINAL SYSTEM received FDA 510(k) clearance on 2012-01-27, under 510(k) number K111294.

Who is the listed applicant for SANTORINI 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 SANTORINI SPINAL SYSTEM?

The FDA product code for SANTORINI SPINAL SYSTEM is MQP.

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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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