SeaSpine Spinous Process System
K-Number: K173334 · 2018-02-22
ApplicantSeaSpine Orthopedics Corporation
Decision Date2018-02-22
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SeaSpine Spinous Process System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2018-02-22 under approval number K173334. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SeaSpine Spinous Process System?
SeaSpine Spinous Process System is a medical device that received FDA 510(k) clearance on 2018-02-22. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K173334.
When was SeaSpine Spinous Process System approved by the FDA?
SeaSpine Spinous Process System received FDA 510(k) clearance on 2018-02-22, under approval number K173334.
What company makes SeaSpine Spinous Process System?
SeaSpine Spinous Process System is manufactured by SeaSpine Orthopedics Corporation.
What is the FDA product code for SeaSpine Spinous Process System?
The FDA product code for SeaSpine Spinous Process System is PEK.
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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.