Curiteva Porous PEEK Laminoplasty System
K-Number: K243137 · 2024-10-28
ApplicantCuriteva, Inc.
Decision Date2024-10-28
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Curiteva Porous PEEK Laminoplasty System is a medical device manufactured by Curiteva, Inc.. It received FDA 510(k) clearance on 2024-10-28 under approval number K243137. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Curiteva Porous PEEK Laminoplasty System?
Curiteva Porous PEEK Laminoplasty System is a medical device that received FDA 510(k) clearance on 2024-10-28. It is manufactured by Curiteva, Inc.. The 510(k) number is K243137.
When was Curiteva Porous PEEK Laminoplasty System approved by the FDA?
Curiteva Porous PEEK Laminoplasty System received FDA 510(k) clearance on 2024-10-28, under approval number K243137.
What company makes Curiteva Porous PEEK Laminoplasty System?
Curiteva Porous PEEK Laminoplasty System is manufactured by Curiteva, Inc..
What is the FDA product code for Curiteva Porous PEEK Laminoplasty System?
The FDA product code for Curiteva Porous PEEK Laminoplasty System is NQW.
Related Clinical Trials
Other Devices by Curiteva, Inc.
Related Devices (Code: NQW)
K160114Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc.
K153735Release Laminoplasty Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
K171413HAVEN Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc.
K181717Life Spine Laminoplasty SystemLife Spine, Inc.
K173215Choice Spine Laminoplasty Fixation SystemChoicespine, LP
K191927Hinged Laminoplasty SystemLife Spine, 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.