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FDA 510(k)

Viking Lumbar Polyaxial Screw System

K-Number: K180655 · 2018-07-13

ApplicantPresidio Surgical
Decision Date2018-07-13
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Viking Lumbar Polyaxial Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Presidio Surgical. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K180655. 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 Viking Lumbar Polyaxial Screw System?

Viking Lumbar Polyaxial Screw System is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Presidio Surgical. The 510(k) number is K180655.

When did Viking Lumbar Polyaxial Screw System receive FDA 510(k) clearance?

Viking Lumbar Polyaxial Screw System received FDA 510(k) clearance on 2018-07-13, under 510(k) number K180655.

Who is the listed applicant for Viking Lumbar Polyaxial Screw System?

The FDA 510(k) record lists Presidio Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Viking Lumbar Polyaxial Screw System?

The FDA product code for Viking Lumbar Polyaxial Screw System is NKB.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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