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FDA 510(k)

CoreLink Midline Fixation System

K-Number: K210539 · 2021-04-15

ApplicantCorelink, LLC
Decision Date2021-04-15
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CoreLink Midline Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Corelink, LLC. It received FDA 510(k) clearance on 2021-04-15 under 510(k) number K210539. 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 CoreLink Midline Fixation System?

CoreLink Midline Fixation System is a medical device that received FDA 510(k) clearance on 2021-04-15. The listed applicant is Corelink, LLC. The 510(k) number is K210539.

When did CoreLink Midline Fixation System receive FDA 510(k) clearance?

CoreLink Midline Fixation System received FDA 510(k) clearance on 2021-04-15, under 510(k) number K210539.

Who is the listed applicant for CoreLink Midline Fixation System?

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

What is the FDA product code for CoreLink Midline Fixation System?

The FDA product code for CoreLink Midline Fixation 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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