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Data / Medical devices / United States / Lockdown Surgical. Inc.

Lockdown Surgical. Inc.: FDA-registered device maker in Chanhassen, MN, United States, 3 510(k) clearances

Lockdown Surgical. Inc. is registered with the FDA (registration 3010237768) in Chanhassen, MN, United States. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 15, 2011. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3010237768
Address
6713 Lakeway Dr., Chanhassen, MN, United States, 55317
Owner or operator
Lockdown Surgical,Inc. (10046743)
Roles
Complaint file establishment
First device listed
February 7, 2024
Registered through
2026
Brand names listed
Depth Gauge, Drill, LockDown Acromialclavicular (AC) Device, LockDown Length Gauge, LockDown Screwdriver, LockDown Washer, Passer, Surgicraft Surgical Mesh

Devices it lists

DeviceProduct codeClassRoleSource
Bit, DrillHTW1Complaint file establishmentaccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Complaint file establishmentaccessdata.fda.gov
Gauge, DepthHTJ1Complaint file establishmentaccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Complaint file establishmentaccessdata.fda.gov
Mesh, Surgical, PolymericFTL2Complaint file establishmentaccessdata.fda.gov
ScrewdriverHXX1Complaint file establishmentaccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Complaint file establishmentaccessdata.fda.gov
Washer, Bolt NutHTN2Complaint file establishmentaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 15, 2011K091207SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICEHTNSubstantially EquivalentSurgicraft , Ltd.accessdata.fda.gov
July 24, 2008K072370SURGICRAFT SURGICAL MESH SYSTEMFTLSubstantially EquivalentSurgicraft , Ltd.accessdata.fda.gov
June 13, 2008K080447SURGICRAFT SCREW FIXATION SYSTEMMBISubstantially EquivalentSurgicraft , Ltd.accessdata.fda.gov

Compare with other makers

Updated February 15, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.