GPS Angled Abutment
K-Number: K153509 · 2016-08-26
Decision Date2016-08-26
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
GPS Angled Abutment is a medical device manufactured by Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2016-08-26 under approval number K153509. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GPS Angled Abutment?
GPS Angled Abutment is a medical device that received FDA 510(k) clearance on 2016-08-26. It is manufactured by Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K153509.
When was GPS Angled Abutment approved by the FDA?
GPS Angled Abutment received FDA 510(k) clearance on 2016-08-26, under approval number K153509.
What company makes GPS Angled Abutment?
GPS Angled Abutment is manufactured by Implant Direct Sybron Manufacturing, LLC.
What is the FDA product code for GPS Angled Abutment?
The FDA product code for GPS Angled Abutment is NHA.
Other Devices by Implant Direct Sybron Manufacturing, LLC
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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.