True Tulip, True M.I.S.
K-Number: K212627 · 2022-02-18
ApplicantInnovative Surgical Designs, Inc.
Decision Date2022-02-18
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
True Tulip, True M.I.S. is a medical device manufactured by Innovative Surgical Designs, Inc.. It received FDA 510(k) clearance on 2022-02-18 under approval number K212627. 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 True Tulip, True M.I.S.?
True Tulip, True M.I.S. is a medical device that received FDA 510(k) clearance on 2022-02-18. It is manufactured by Innovative Surgical Designs, Inc.. The 510(k) number is K212627.
When was True Tulip, True M.I.S. approved by the FDA?
True Tulip, True M.I.S. received FDA 510(k) clearance on 2022-02-18, under approval number K212627.
What company makes True Tulip, True M.I.S.?
True Tulip, True M.I.S. is manufactured by Innovative Surgical Designs, Inc..
What is the FDA product code for True Tulip, True M.I.S.?
The FDA product code for True Tulip, True M.I.S. is NKB.
Other Devices by Innovative Surgical Designs, Inc.
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.