SeaSpine Reef TH System
K-Number: K193636 · 2020-04-24
ApplicantSeaSpine Orthopedics Corporation
Decision Date2020-04-24
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SeaSpine Reef TH System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2020-04-24 under approval number K193636. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SeaSpine Reef TH System?
SeaSpine Reef TH System is a medical device that received FDA 510(k) clearance on 2020-04-24. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K193636.
When was SeaSpine Reef TH System approved by the FDA?
SeaSpine Reef TH System received FDA 510(k) clearance on 2020-04-24, under approval number K193636.
What company makes SeaSpine Reef TH System?
SeaSpine Reef TH System is manufactured by SeaSpine Orthopedics Corporation.
What is the FDA product code for SeaSpine Reef TH System?
The FDA product code for SeaSpine Reef TH System is MAX.
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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.