SeaSpine 7D Navigation Instruments
K-Number: K222753 · 2022-12-09
ApplicantSeaSpine Orthopedics Corporation
Decision Date2022-12-09
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
SeaSpine 7D Navigation Instruments is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2022-12-09 under approval number K222753. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SeaSpine 7D Navigation Instruments?
SeaSpine 7D Navigation Instruments is a medical device that received FDA 510(k) clearance on 2022-12-09. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K222753.
When was SeaSpine 7D Navigation Instruments approved by the FDA?
SeaSpine 7D Navigation Instruments received FDA 510(k) clearance on 2022-12-09, under approval number K222753.
What company makes SeaSpine 7D Navigation Instruments?
SeaSpine 7D Navigation Instruments is manufactured by SeaSpine Orthopedics Corporation.
What is the FDA product code for SeaSpine 7D Navigation Instruments?
The FDA product code for SeaSpine 7D Navigation Instruments is OLO.
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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.