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FDA 510(k)

PHANTOM PLUS CERAMIC CAGE SYSTEM

K-Number: K121892 · 2012-08-24

ApplicantAmedica Corp.
Decision Date2012-08-24
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PHANTOM PLUS CERAMIC CAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Amedica Corp.. It received FDA 510(k) clearance on 2012-08-24 under 510(k) number K121892. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHANTOM PLUS CERAMIC CAGE SYSTEM?

PHANTOM PLUS CERAMIC CAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-08-24. The listed applicant is Amedica Corp.. The 510(k) number is K121892.

When did PHANTOM PLUS CERAMIC CAGE SYSTEM receive FDA 510(k) clearance?

PHANTOM PLUS CERAMIC CAGE SYSTEM received FDA 510(k) clearance on 2012-08-24, under 510(k) number K121892.

Who is the listed applicant for PHANTOM PLUS CERAMIC CAGE SYSTEM?

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

What is the FDA product code for PHANTOM PLUS CERAMIC CAGE SYSTEM?

The FDA product code for PHANTOM PLUS CERAMIC CAGE SYSTEM is MAX.

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Related Devices (Code: MAX)

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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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