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FDA 510(k)

SP-LINK™ System

K-Number: K182352 · 2018-11-21

ApplicantMedical Designs, LLC
Decision Date2018-11-21
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SP-LINK™ System is the device name listed in this FDA 510(k) record. The listed applicant is Medical Designs, LLC. It received FDA 510(k) clearance on 2018-11-21 under 510(k) number K182352. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SP-LINK™ System?

SP-LINK™ System is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is Medical Designs, LLC. The 510(k) number is K182352.

When did SP-LINK™ System receive FDA 510(k) clearance?

SP-LINK™ System received FDA 510(k) clearance on 2018-11-21, under 510(k) number K182352.

Who is the listed applicant for SP-LINK™ System?

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

What is the FDA product code for SP-LINK™ System?

The FDA product code for SP-LINK™ System is PEK.

Other records listing Medical Designs, 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.

K181591Fixated Asfora BULLET CAGE® (FABC)

Related Devices (Code: PEK)

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.

K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLCK234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3Spinal Simplicity, LLCK233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLCK232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospineK231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.K223790Huvex Interspinous Fusion SystemDio Medical Corp.

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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