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FDA 510(k)

SETx Pedicle Screw System

K-Number: K170611 · 2017-05-25

ApplicantXenco Medical, LLC
Decision Date2017-05-25
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SETx 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 2017-05-25 under 510(k) number K170611. 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 SETx Pedicle Screw System?

SETx Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2017-05-25. The listed applicant is Xenco Medical, LLC. The 510(k) number is K170611.

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

SETx Pedicle Screw System received FDA 510(k) clearance on 2017-05-25, under 510(k) number K170611.

Who is the listed applicant for SETx 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 SETx Pedicle Screw System?

The FDA product code for SETx Pedicle Screw System is NKB.

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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.

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