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Data / Medical devices / Ireland / Stryker Macroom

Stryker Macroom: FDA-registered device maker in Co Cork Munster, Ireland, 15 510(k) clearances

Stryker Macroom is registered with the FDA (registration 3008337808) in Co Cork Munster, Ireland. It lists 14 device types. The FDA files 15 510(k) clearances under its listings, the newest dated May 11, 2021. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Stryker Macroom
FDA registration number
3008337808
Address
Hartnetts Cross Macroom, Co Cork Munster, Ireland, P12 XA50
Owner or operator
STRYKER CORP. (1811755)
Roles
Contract manufacturer, Manufacturer
First device listed
June 9, 1986
Registered through
2027
Brand names listed
3.9mm Omega Drill, 4.75mm AlphaVent and Omega Drill, 5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill, ACL Reconstruction Accessories, ACL Workstation, AEQUALIS PERFORM REVERSED, AEQUALIS PerFORM Reversed & AEQUALIS PerFORM+ Reversed, AEQUALIS REVERSED PROSTHESIS and more

Devices it lists

DeviceProduct codeClassRoleSource
Bit, DrillHTW1Contract manufacturer, Manufactureraccessdata.fda.gov
Cement ObturatorLZN2Contract manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufactureraccessdata.fda.gov
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerHSN2Manufactureraccessdata.fda.gov
Prosthesis, Elbow, Constrained, CementedJDC2Contract manufactureraccessdata.fda.gov
Prosthesis, Elbow, Hemi-, Radial, PolymerKWI2Contract manufactureraccessdata.fda.gov
Prosthesis, Elbow, Semi-Constrained, CementedJDB2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedHSD2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer CementedKWT2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedPAO2Contract manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS2Contract manufacturer, Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufacturer, Manufactureraccessdata.fda.gov
ScrewdriverHXX1Contract manufactureraccessdata.fda.gov
Shoulder Prosthesis, Reverse ConfigurationPHX2Contract manufacturer, Manufactureraccessdata.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
May 11, 2021K203228DART-FIRE EDGE Cannulated Screw SystemHWCSubstantially EquivalentWright Medicalaccessdata.fda.gov
November 15, 2016K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHXSubstantially EquivalentTornier, Inc.accessdata.fda.gov
June 10, 2016K160975Aequalis PerFORM+ Shoulder SystemKWSSubstantially EquivalentTornier, Inc.accessdata.fda.gov
April 25, 2014K140749INFINITY TOTAL ANKLE SYSTEMHSNSubstantially EquivalentWrightmedicaltechnologyincaccessdata.fda.gov
October 16, 2013K131231AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESISPHXSubstantially EquivalentTornier S.A.S.accessdata.fda.gov
April 1, 2013K123954INFINITY TOTAL ANKLE SYSTEMHSNSubstantially EquivalentWrightmedicaltechnologyincaccessdata.fda.gov
March 9, 2012K113413ASCEND SHOULDER SYSTEMKWSSubstantially EquivalentTornier, Inc.accessdata.fda.gov
July 20, 2006K061439AEQUALIS REVERSED PROSTHESISPHXSubstantially EquivalentTornieraccessdata.fda.gov
March 2, 2006K060209AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEMKWSSubstantially EquivalentTornieraccessdata.fda.gov
March 16, 2005K050316AEQUALIS REVERSED SHOULDER PROSTHESISPHXSubstantially EquivalentTornieraccessdata.fda.gov
August 25, 2004K041873AEQUALIS REVERSED SHOULDER PROSTHESISPHXSubstantially EquivalentTornieraccessdata.fda.gov
June 17, 2004K041339AEQUALIS SHOULDER SYSTEMKWSSubstantially EquivalentTornieraccessdata.fda.gov
June 22, 2000K994393AEQUALIS UNIVERSAL SHOULDER GLENOIDKWSSubstantially EquivalentTornieraccessdata.fda.gov
March 10, 2000K994392AEQUALIS SHOULDER FRACTURE SYSTEMKWSSubstantially EquivalentTornieraccessdata.fda.gov
September 27, 1995K952928AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONSKWSSubstantially EquivalentTornieraccessdata.fda.gov

Compare with other makers

Updated May 11, 2021. 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.