Z-LINKPC System
K-Number: K162575 · 2017-03-03
ApplicantZavation, LLC
Decision Date2017-03-03
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Z-LINKPC System is a medical device manufactured by Zavation, LLC. It received FDA 510(k) clearance on 2017-03-03 under approval number K162575. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Z-LINKPC System?
Z-LINKPC System is a medical device that received FDA 510(k) clearance on 2017-03-03. It is manufactured by Zavation, LLC. The 510(k) number is K162575.
When was Z-LINKPC System approved by the FDA?
Z-LINKPC System received FDA 510(k) clearance on 2017-03-03, under approval number K162575.
What company makes Z-LINKPC System?
Z-LINKPC System is manufactured by Zavation, LLC.
What is the FDA product code for Z-LINKPC System?
The FDA product code for Z-LINKPC System is NKG.
Other Devices by Zavation, LLC
Related Devices (Code: NKG)
K161032neon3 universal OCT spinal stabilizationUlrich GmbH & Co. KG
K162300Reform® POCT SystemPrecision Spine, Inc.
K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.
K161591QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.
K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC
K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, 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.