ANATOMIC PEEK PTC Cervical Fusion System
K-Number: K160528 · 2016-03-28
ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2016-03-28
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ANATOMIC PEEK PTC Cervical Fusion System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2016-03-28 under approval number K160528. 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 ANATOMIC PEEK PTC Cervical Fusion System?
ANATOMIC PEEK PTC Cervical Fusion System is a medical device that received FDA 510(k) clearance on 2016-03-28. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K160528.
When was ANATOMIC PEEK PTC Cervical Fusion System approved by the FDA?
ANATOMIC PEEK PTC Cervical Fusion System received FDA 510(k) clearance on 2016-03-28, under approval number K160528.
What company makes ANATOMIC PEEK PTC Cervical Fusion System?
ANATOMIC PEEK PTC Cervical Fusion System is manufactured by Medtronic Sofamor Danek USA, Inc..
What is the FDA product code for ANATOMIC PEEK PTC Cervical Fusion System?
The FDA product code for ANATOMIC PEEK PTC Cervical Fusion 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.