Hinged Laminoplasty System
K-Number: K191927 · 2019-09-20
ApplicantLife Spine, Inc.
Decision Date2019-09-20
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Hinged Laminoplasty System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2019-09-20 under approval number K191927. 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 Hinged Laminoplasty System?
Hinged Laminoplasty System is a medical device that received FDA 510(k) clearance on 2019-09-20. It is manufactured by Life Spine, Inc.. The 510(k) number is K191927.
When was Hinged Laminoplasty System approved by the FDA?
Hinged Laminoplasty System received FDA 510(k) clearance on 2019-09-20, under approval number K191927.
What company makes Hinged Laminoplasty System?
Hinged Laminoplasty System is manufactured by Life Spine, Inc..
What is the FDA product code for Hinged Laminoplasty System?
The FDA product code for Hinged Laminoplasty System is NQW.
Other Devices by Life Spine, Inc.
Related Devices (Code: NQW)
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K171413HAVEN Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc.
K181717Life Spine Laminoplasty SystemLife Spine, Inc.
K173215Choice Spine Laminoplasty Fixation SystemChoicespine, LP
K191169NuVasive® Camber Laminoplasty SystemNu Vasive, Incorporated
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.