Single Platform SP1 Implant System
K-Number: K232418 · 2023-12-01
ApplicantSouthern Implants (Pty), Ltd.
Decision Date2023-12-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Single Platform SP1 Implant System is a medical device manufactured by Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2023-12-01 under approval number K232418. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Single Platform SP1 Implant System?
Single Platform SP1 Implant System is a medical device that received FDA 510(k) clearance on 2023-12-01. It is manufactured by Southern Implants (Pty), Ltd.. The 510(k) number is K232418.
When was Single Platform SP1 Implant System approved by the FDA?
Single Platform SP1 Implant System received FDA 510(k) clearance on 2023-12-01, under approval number K232418.
What company makes Single Platform SP1 Implant System?
Single Platform SP1 Implant System is manufactured by Southern Implants (Pty), Ltd..
What is the FDA product code for Single Platform SP1 Implant System?
The FDA product code for Single Platform SP1 Implant System is DZE.
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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.