Tiger 2 System
K-Number: K243908 · 2025-02-03
ApplicantZavation Medical Products, LLC
Decision Date2025-02-03
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Tiger 2 System is a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2025-02-03 under approval number K243908. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tiger 2 System?
Tiger 2 System is a medical device that received FDA 510(k) clearance on 2025-02-03. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K243908.
When was Tiger 2 System approved by the FDA?
Tiger 2 System received FDA 510(k) clearance on 2025-02-03, under approval number K243908.
What company makes Tiger 2 System?
Tiger 2 System is manufactured by Zavation Medical Products, LLC.
What is the FDA product code for Tiger 2 System?
The FDA product code for Tiger 2 System is NKB.
Other Devices by Zavation Medical Products, LLC
Related Devices (Code: NKB)
K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.
K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC
K162912VIPER PRIME additions to the VIPER® SystemMedos International SARL
K162160Preference Elite Pedicle Screw SystemAmedica Corporation
K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG
K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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.