Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616696

FEI Number

3003164255

Entity Name

STRYKER IRELAND LTD., INSTRUMENTS DIVISION

City/State/Country

CARRIGTWOHILL, CO.CORK Munster, IE

Establishment Address

CARRIGTWOHILL BUSINESS &, TECHNOLOGY PARK, CARRIGTWOHILL, CO.CORK Munster --, 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stryker(R) Consolidated Operating Room Equipment (CORE) System 4cm Angled Irrigation Clip 4cm Straight Irrigation Clip RemB Micro Drill 5MM FLEXIBLE REAMER 6MM FLEXIBLE REAMER 11MM FLEXIBLE REAMER 7.5MM FLEXIBLE REAMER 4.5MM FLEXIBLE REAMER 7MM FLEXIBLE REAMER 12MM FLEXIBLE REAMER 11.5MM FLEXIBLE REAMER 8MM FLEXIBLE REAMER 6.5MM FLEXIBLE REAMER 9.5MM FLEXIBLE REAMER FLEXIBLE GUIDE PIN VERSITOMIC STERILE FLEXIBLE PIN 10MM FLEXIBLE REAMER 5.5MM FLEXIBLE REAMER 8.5MM FLEXIBLE REAMER 9MM FLEXIBLE REAMER 10.5MM FLEXIBLE REAMER AEQUALIS REVERSED BIT General Surgical Bits Stryker Aria Pneumatic System RIO PKA System NexFix IMN Instruments drill Made-To-Order Tornier Simpliciti Shoulder System MaxTorque Compression Staple System Latitude EV Aequalis Perform+ CalcLock MaxLock Tornier Perform Humeral System Tornier Perform Reversed Pangea Torque Limiting Adapter Aequalis Flex Revive Tornier Extraction Tornier Humeral Nail Pangea Platform Hoffmann LRF 4 mm ENT MicroDebrider JAGUAR Mako Partial Knee 0485-840-000 - XL Round Diamond Bur, 4 mm 0485-860-000 - XL Round Diamond Bur, 5.5 mm Dual Edge Shaver Blade 4mm Dual Edge Shaver Blade 5.5mm Tomcat HC Shaver Blade 4mm Aggressive Max Shaver Blade 3.5mm Smooth Bite Shaver Blade 3.5mm Dual Edge Shaver Blade 3.5mm Bursector 5.5 mm Bursector 4 mm 12cm iQ Apex 360 12cm iQ Standard 10cm iQ Broad Knife 12cm iQ Serrated Large 12cm iQ Barracuda 12cm iQ Large 18cm iQ Apex Micro Claw SONOPET IQ CONSOLE 18cm iQ Micro Claw 12cm iQ Micro 12cm iQ 120 Claw 11cm iQ Knife 12cm iQ Micro Claw 12cm iQ Claw 20cm iQ Apex 360 11cm iQ Apex Knife 20cm iQ Standard add name Stryker Leibinger Colorado Microdissection Needle 7.5MM Round IRRIGATION Mako TKA System ORTHOVAC CASTVAC Kirschner Wire 4mm TomCat Shaver Blades 5mm HellCat Shaver Blades Aggressive Max Shaver Blade 3.5mm Dual Edge Shaver Blade 4mm Smooth Bite Shaver Blade 3.5mm Tomcat HC Shaver Blade 4mm Dual Edge Shaver Blade 3.5mm Dual Edge Shaver Blade 5.5mm ATTACHMENTS PKG., DUAL EDGE SHAVER BLADE - 5.5MM HMENTS SURGICAL INSTRUMENT MOTORS AND ACCE SMOOTH BITE SHAVER BLADE - 3.5MM SAW BLADE HLS KNEETEC PKG., AGGRESSIVE MAX SHAVER BLADE - 3.5MM Mako Shoulder Application

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2015-05-03
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2015-05-03
EJL	Bur, Dental	Dental	Class 1	872.3240	1992-12-22
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2014-07-17
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	1995-07-11
HBB	Motor, Drill, Pneumatic	Neurology	Class 2	882.4370	2007-12-03
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	1995-07-11
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2015-09-24
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2006-12-12
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	1996-02-06
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2021-07-08
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2021-07-08
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-11-06
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2004-11-15
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2022-02-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-05-20
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-12-19
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2015-04-24
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2025-03-19
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	1992-12-26
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2015-08-07
HBF	Drills, Burrs, Trephines & Accessories (Compound, Powered)	Neurology	Class 2	882.4305	2009-04-30
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-07-26
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2024-07-26
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2024-07-26
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2024-07-26
LGH	Instrument, Cast Removal, Ac-Powered	Orthopedic	Class 1	888.5960	2006-12-12
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2011-11-28
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2004-11-15
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-02-23
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-11-13

Official Correspondent

No official correspondent registered.

US Agent Details

Kim Wiersema Business: STRYKER INSTRUMENTS Email: kim.wiersema@stryker.com Phone: (269) 2545351

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

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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
K964548	Linvatec Corp.	APEX UNIVERSAL DRIVE SYSTEM	1997-01-17
K253772	Adeor Medical AG	Velocity Alpha MR High Speed Surgical Drill System	2026-03-06
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2026	Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany	2	AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Z-0027-2026	Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany	2	AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616696. Last updated year: 2026. Please use registration number 9616696 when referencing this establishment in official correspondence.