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FDA 510(k)

SeaSpine Skipjack System

K-Number: K193418 · 2020-03-13

ApplicantSeaSpine Orthopedics Corporation
Decision Date2020-03-13
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SeaSpine Skipjack System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2020-03-13 under approval number K193418. 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 Skipjack System?

SeaSpine Skipjack System is a medical device that received FDA 510(k) clearance on 2020-03-13. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K193418.

When was SeaSpine Skipjack System approved by the FDA?

SeaSpine Skipjack System received FDA 510(k) clearance on 2020-03-13, under approval number K193418.

What company makes SeaSpine Skipjack System?

SeaSpine Skipjack System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for SeaSpine Skipjack System?

The FDA product code for SeaSpine Skipjack System is MAX.

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Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

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.

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