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FDA 510(k)

SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System

K-Number: K180665 · 2018-11-28

ApplicantK2m, LLC
Decision Date2018-11-28
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System is the device name listed in this FDA 510(k) record. The listed applicant is K2m, LLC. It received FDA 510(k) clearance on 2018-11-28 under 510(k) number K180665. 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 Corpectomy Cage System, CAPRI Corpectomy Cage System?

SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System is a medical device that received FDA 510(k) clearance on 2018-11-28. The listed applicant is K2m, LLC. The 510(k) number is K180665.

When did SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System receive FDA 510(k) clearance?

SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System received FDA 510(k) clearance on 2018-11-28, under 510(k) number K180665.

Who is the listed applicant for SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System?

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

What is the FDA product code for SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System?

The FDA product code for SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System is MQP.

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Related Devices (Code: MQP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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