NorthStar OCT Spinal System
K-Number: K193615 · 2020-03-25
ApplicantSeaSpine Orthopedics Corporation
Decision Date2020-03-25
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
NorthStar OCT Spinal System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2020-03-25 under approval number K193615. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NorthStar OCT Spinal System?
NorthStar OCT Spinal System is a medical device that received FDA 510(k) clearance on 2020-03-25. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K193615.
When was NorthStar OCT Spinal System approved by the FDA?
NorthStar OCT Spinal System received FDA 510(k) clearance on 2020-03-25, under approval number K193615.
What company makes NorthStar OCT Spinal System?
NorthStar OCT Spinal System is manufactured by SeaSpine Orthopedics Corporation.
What is the FDA product code for NorthStar OCT Spinal System?
The FDA product code for NorthStar OCT Spinal System is NKG.
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Related Devices (Code: NKG)
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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.