Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Xenco Medical Pedicle Screw System

K-Number: K160986 · 2016-05-04

ApplicantXenco Medical, LLC
Decision Date2016-05-04
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Xenco Medical Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Xenco Medical, LLC. It received FDA 510(k) clearance on 2016-05-04 under 510(k) number K160986. 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 Xenco Medical Pedicle Screw System?

Xenco Medical Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2016-05-04. The listed applicant is Xenco Medical, LLC. The 510(k) number is K160986.

When did Xenco Medical Pedicle Screw System receive FDA 510(k) clearance?

Xenco Medical Pedicle Screw System received FDA 510(k) clearance on 2016-05-04, under 510(k) number K160986.

Who is the listed applicant for Xenco Medical Pedicle Screw System?

The FDA 510(k) record lists Xenco Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xenco Medical Pedicle Screw System?

The FDA product code for Xenco Medical Pedicle Screw System is NKB.

Other records listing Xenco Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243673Xenco Medical CancelleX Cervical Interbody SystemK223059Xenco Medical InterAlign Cervical Interbody SystemK213456Xenco Medical Multilevel CerviKitK191074Sorrento Bone Graft SubstituteK190364CancelleX Porous Titanium Lumbar Interbody DeviceK173933Sorrento Bioglass Bone Graft Substitute

View all 11 devices →

Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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.

↑