Sapphire Cervical Implant System
K-Number: K172674 · 2017-11-02
ApplicantSapphire Medical Group
Decision Date2017-11-02
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Sapphire Cervical Implant System is a medical device manufactured by Sapphire Medical Group. It received FDA 510(k) clearance on 2017-11-02 under approval number K172674. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sapphire Cervical Implant System?
Sapphire Cervical Implant System is a medical device that received FDA 510(k) clearance on 2017-11-02. It is manufactured by Sapphire Medical Group. The 510(k) number is K172674.
When was Sapphire Cervical Implant System approved by the FDA?
Sapphire Cervical Implant System received FDA 510(k) clearance on 2017-11-02, under approval number K172674.
What company makes Sapphire Cervical Implant System?
Sapphire Cervical Implant System is manufactured by Sapphire Medical Group.
What is the FDA product code for Sapphire Cervical Implant System?
The FDA product code for Sapphire Cervical Implant System is ODP.
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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.