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FDA 510(k)

Swedge™ Pedicle Screw Fixation System

K-Number: K170045 · 2017-06-26

ApplicantSpinal Resources, Inc.
Decision Date2017-06-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Swedge™ Pedicle Screw Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Resources, Inc.. It received FDA 510(k) clearance on 2017-06-26 under 510(k) number K170045. 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 Swedge™ Pedicle Screw Fixation System?

Swedge™ Pedicle Screw Fixation System is a medical device that received FDA 510(k) clearance on 2017-06-26. The listed applicant is Spinal Resources, Inc.. The 510(k) number is K170045.

When did Swedge™ Pedicle Screw Fixation System receive FDA 510(k) clearance?

Swedge™ Pedicle Screw Fixation System received FDA 510(k) clearance on 2017-06-26, under 510(k) number K170045.

Who is the listed applicant for Swedge™ Pedicle Screw Fixation System?

The FDA 510(k) record lists Spinal Resources, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Swedge™ Pedicle Screw Fixation System?

The FDA product code for Swedge™ Pedicle Screw Fixation System is NKB.

Related Clinical Trials

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.

NCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITING

Other records listing Spinal Resources, Inc. 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.

K252461Swedge™ Pedicle Screw Fixation System Bezier RodK230482Swedge™ Pedicle Screw Fixation SystemK152662S-Wire

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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