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Data / Medical devices / United States / Stryker US Supply Chain Operations

Stryker US Supply Chain Operations: FDA-registered device maker in Plainfield, IN, United States, 21 510(k) clearances

Stryker US Supply Chain Operations is registered with the FDA (registration 3012497308) in Plainfield, IN, United States. It lists 17 device types. The FDA files 21 510(k) clearances under its listings, the newest dated December 19, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3012497308
Address
1551 Perry Rd Ste 101, Plainfield, IN, United States, 46168
Owner or operator
STRYKER CORP. (1811755)
Roles
Repackager or relabeler
First device listed
March 14, 1995
Registered through
2026
Brand names listed
ACM, AEQUALIS PERFORM, AUTOPLEX, AXS Catalyst Distal Access Catheter, AXS Universal Aspiration System (AXS Catalyst 7 Distal Access Catheter), AXS Vecta 46 Intermediate Catheter, AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Exhaust, SurgicalFYD2Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Ward Use, Portable, Ac-PoweredJCX2Repackager or relabeleraccessdata.fda.gov
Catheter, Continuous FlushKRA2Repackager or relabeleraccessdata.fda.gov
Catheter, Intravascular Occluding, TemporaryMJN2Repackager or relabeleraccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Repackager or relabeleraccessdata.fda.gov
Catheter, PercutaneousDQY2Repackager or relabeleraccessdata.fda.gov
Catheter, Percutaneous, NeurovasculatureQJP2Repackager or relabeleraccessdata.fda.gov
Catheter, Thrombus RetrieverNRY2Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Gown, SurgicalFYA2Repackager or relabeleraccessdata.fda.gov
Helmet, SurgicalFXZ1Repackager or relabeleraccessdata.fda.gov
Hood, SurgicalFXY2Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Repackager or relabeleraccessdata.fda.gov
Lavage, JetFQH2Repackager or relabeleraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Repackager or relabeleraccessdata.fda.gov
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke TreatmentPOL2Repackager or relabeleraccessdata.fda.gov
Wire, Guide, CatheterDQX2Repackager or relabeleraccessdata.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
December 19, 2024K241768Broadway 8 CatheterQJPSubstantially EquivalentStryker Neurovascularaccessdata.fda.gov
December 19, 2024K241637Echo Intracranial Base CatheterQJPSubstantially EquivalentStryker Neurovascularaccessdata.fda.gov
October 16, 2024K241272Stryker Steri-Shield 8 Surgical Hoods and TogasFYASubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
December 9, 2022K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)JCXSubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
August 27, 2021K202752AXS Vecta 46 Intermediate CatheterQJPSubstantially EquivalentStryker Neurovascularaccessdata.fda.gov
March 21, 2020K200493Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, PulloverFXYSubstantially EquivalentStryker Corporationaccessdata.fda.gov
February 27, 2020K200206AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate CatheterQJPSubstantially EquivalentStryker Neurovascularaccessdata.fda.gov
February 7, 2020K200117Trevo NXT ProVue RetrieverPOLSubstantially EquivalentStrykeraccessdata.fda.gov
November 22, 2019K192122Trevo Trak 21 MicrocatheterDQOSubstantially EquivalentStrykeraccessdata.fda.gov
March 13, 2019K183464AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)NRYSubstantially EquivalentStrykeraccessdata.fda.gov
March 18, 2018K173841AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cmNRYSubstantially EquivalentStrykeraccessdata.fda.gov
June 12, 2015K150616Trevo XP ProVue Retriever (4x30mm)NRYSubstantially EquivalentConcentric Medical, Inc.accessdata.fda.gov
December 4, 2014K143145SafeAir Smoke PencilGEISubstantially EquivalentLina Medical Apsaccessdata.fda.gov
June 26, 2014K140588FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENSFXYSubstantially EquivalentStryker Corporationaccessdata.fda.gov
January 13, 2014K132641MODIFIED TREVO PROVUE RETRIEVERNRYSubstantially EquivalentConcentric Medical, Inc.accessdata.fda.gov
December 20, 2013K132671STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEMJCXSubstantially EquivalentStryker Corporationaccessdata.fda.gov
January 11, 2013K122576TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANTMJNSubstantially EquivalentStryker Neurovascularaccessdata.fda.gov
April 20, 2012K113778EXCELSIOR XT-27 MICROCATHETERDQYSubstantially EquivalentStryker Neurovascularaccessdata.fda.gov
March 9, 2012K113260MODIFIED CONCENTIRC MICROCATHETERDQOSubstantially EquivalentConcentric Medical, Inc.accessdata.fda.gov
March 23, 2007K063005STRYKER T6 HOODS AND TOGASFYASubstantially EquivalentStryker Instrumentsaccessdata.fda.gov
July 1, 1997K971254TRANSEND EX PLATINUM GUIDEWIREDQXSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov

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Updated December 19, 2024. 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.