Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040335671

FEI Number

3040335671

Entity Name

Stryker Ireland Ltd. Instruments Division, Innovation Centre

City/State/Country

Carrigtwohill Cork (County), IE

Establishment Address

Carrigtwohill Business & Technology Park, Carrigtwohill Cork (County) T45 PN79, IE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K112593

PMA Number

N/A

All Registered Proprietary Names

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 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 IRRIGATION 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 Kirschner Wire 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 PCD PREC. SYS LONG TUBE W/VertaPlex HV PCD kit Short tube with Vertaplex HV PCD Kit Long tube with VertaPlex HV Autoplex with Vertaplex HV AutoPlex M4 Kit B: Cement Mixer with VertaPlex ® HV Manifold compatible AutoPlex M4 Kit A: Cement Mixer with VertaPlex ® HV 4 mm ENT MicroDebrider JAGUAR ORTHOVAC CASTVAC 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 Stryker(R) Consolidated Operating Room Equipment (CORE) System 4cm Angled Irrigation Clip 4cm Straight Irrigation Clip RemB Micro Drill

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2006-12-12
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2022-02-17
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-12-19
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	1992-12-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-05-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-02-08
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	1995-07-11
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2011-11-28
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2006-12-12
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2022-01-17
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2022-01-17
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2022-01-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-01-08
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2005-02-04
DWH	Blade, Saw, Surgical, Cardiovascular	General, Plastic Surgery	Class 1	878.4820	2006-12-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-05-09
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2004-11-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-03-19
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	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
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2015-05-10
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-02-23
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	1995-07-11
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2015-09-10
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2015-09-10
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
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	1996-02-06
LGH	Instrument, Cast Removal, Ac-Powered	Orthopedic	Class 1	888.5960	2006-12-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-06-25
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2017-02-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-04-22
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2020-04-22
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2020-04-22
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2020-04-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-11-26
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2014-12-08
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2013-08-09
EJL	Bur, Dental	Dental	Class 1	872.3240	1992-12-22
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2004-11-15
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2014-07-17

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.

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Related 510(k) Records

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Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
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-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3040335671. Last updated year: 2026. Please use registration number 3040335671 when referencing this establishment in official correspondence.