Stryker Macroom

FDA Device Registration & Listing · Co Cork Munster, IE · Registration 3008337808

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008337808
FEI Number
3008337808
Entity Name
Stryker Macroom
City/State/Country
Co Cork Munster, IE
Establishment Address
Hartnetts Cross, Macroom, Co Cork Munster P12 XA50, IE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
STRYKER CORP. (Owner Number: 1811755)
Owner / Operator Contact Address
4100 East Milham Ave., Kalamazoo, MI 49001, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Aequalis Shoulder System - glenoid AEQUALIS REVERSED PROSTHESIS Aequalis Ascend Flex Shoulder System Aequalis Reversed Shoulder Prosthesis DART-FIRE EDGE Cannulated Screws Aequalis Shoulder System Tornier Perform Anatomic Glenoid LATITUDE EV ORTHOLOC 3DI Ankle Fusion System ORTHOLOC, ORTHOLOC 3Di ORTHOLOC ORTHOLOC 3Di PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Aequalis Reversed Titanium Glenoid Sphere Aequalis Ascend Flex Titanium Head Aequalis Reversed II - Threaded Post Baseplate Aequalis Shoulder System Aequalis Shoulder Fracture System OSTEONICS VARIOUS TWIST DRILLS Inter-Lock System Phoenix CinchLock BioZip System Xcel Anchor System TwinLoop FLEX ACL Workstation Universal ACL Instrumentation NanoTack Meniscal Transplant Set Cross-Screw System Mainstay Zip Anchor System TwinLoop Anchor System NanoTack Flex ICONIX All Suture Anchor System MicroFX™ DRILL BIT MANUAL DRILL BIT Tornier Drill bits (all) General Instruments 3.9mm Omega Drill 4.75mm AlphaVent and Omega Drill VariAx, Tap For Bone Screws 5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill Variable Angle Fixation Knotilus+ 2.9x12.5mm Drill Knotilus+ 2.4x11.3mm Drill Knotilus+ 2.9x12.5mm Drill, Hard Bone Knotilus+ 2.9x15.5mm Drill Knotilus+ 2.4x8.9mm Drill, Hard Bone, Hip Knotilus+ 2.4X11.3mm Drill, Hard Bone Knotilus+ 2.9x15.5mm Drill, Hard Bone Knotilus+ 2.4x8.9mm Drill, Hip Knotilus+ 2.9x12.5mm Drill, Hard Bone, Hip Knotilus+ 2.9x12.5mm Drill, Hip PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Elbow joint radial (hemi-elbow) polymer prosthesis Elbow joint metal/polymer semi-constrained cemented prosthesis Latitude Elbow Prosthesis LATITUDE EV ORTHOLOC 3Di Foot Reconstruction System ORTHOLOC 3Di Hallux System Aequalis LATITUDE EV Tornier Perform Reversed Glenoid & Tornier Perform Reversed Augmented Glenoid AEQUALIS PerFORM Reversed & AEQUALIS PerFORM+ Reversed Tornier Perform® Reversed Glenoid Cannulated Glenospheres Cement Restrictor Tornier Flex Shoulder System Aequalis" Ascend" Flex Shoulder System AEQUALIS REVERSED SHOULDER PROSTHESIS TORNIER PERFORM™ HUMERAL SYSTEM Sz 2 Plus stem Tornier Perform™ Humeral System TORNIER PERFORM™ HUMERAL SYSTEM Sz 2 stem TORNIER PERFORM™ HUMERAL SYSTEM Sz 3 stem TORNIER PERFORM™ HUMERAL SYSTEM Sz 3 Plus stem Aequalis Shoulder system ASCEND SHOULDER SYSTEM Aequalis Reversed Fracture Shoulder Prosthesis Aequalis Shoulder Fracture System Aequalis Reversed Shoulder Prosthesis Aequalis Ascend FLEX Shoulder System Graft Box Compression Screw Graft Box Locking Screw Graft releasing bell central blade Bell Saw Graft Sizer Graft releasing bell external blade Blade Unlocker Graft Box Body Curved Reamer Head Graft Releasing Bell Handle Releasing Bell Central Blade Tornier Perform Reversed MonoPost Glenoid Flat Humeral Reamer Head Graft Extractor Releasing Bell External Blade Releasing Bell Shaft Baseplate post drill Flat Glenoid Reamer Head Graft Box Washer Graft Box Wedge Graft Container Graft releasing bell shaft Flat glenoid Neo reamer head Post Drill Curved glenoid Neo reamer head Graft Releasing Bell Glenoid Pin Guide

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-23
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-04-23
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-06-10
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2021-04-23
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2021-04-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-04-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-22
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
HTW Bit, Drill Orthopedic Class 1 888.4540 2001-02-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2021-04-22
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2021-04-22
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2021-04-22
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2021-04-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-04-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2021-04-23
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2021-04-23
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-23
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-11-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-11-23
LZN Cement Obturator General, Plastic Surgery Class 2 878.3300 2021-04-22
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-04-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-23
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-23
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-23
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2021-04-23
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-23
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-04-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-22
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-22
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-04-23
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-04-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2026-01-14
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2026-01-14

Official Correspondent

No official correspondent registered.

US Agent Details

Jeanine Redden Email: jeanine.redden@stryker.com Phone: (901) 8674522

Related Public Records

Same Entity

STRYKER CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003897776 BIOMIMETIC THERAPEUTICS,LLC FRANKLIN, TN, US
3040801290 Inari Medical, Costa Rica S.A. Grecia Alajuela, CR
2031049 TMJ Solutions, LLC San Buenaventura, CA, US
3016573902 Ortho-Space Ltd. Caesarea Haifa, IL
3010411911 POM Medical, LLC Moorpark, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K904879 Endotec, Inc. BEUCHEL-PAPPAS GLENOID COMPONENT 1991-01-28
K141345 Tornier S.A.S. AEQUALIS FX2 2014-11-18
K984202 Howmedica, Inc. HOWMEDICA HUMERAL INTERCALARY SYSTEM 1999-02-05
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.
Z-0027-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008337808. Last updated year: 2026. Please use registration number 3008337808 when referencing this establishment in official correspondence.
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