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Stryker Instruments

United States·US-MF-000025219

Last updated September 17, 2026

Information

Country: United States
Address: 1941, Stryker Way, Portage, United States
Website: www.stryker.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 8002533210
PRRC Contact: Caitlyn Covault
EUDAMED SRN: US-MF-000025219
FDA FEI Number: 3015967359
DUNS Number: —

Catalogue (93)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
J-Notch Burs	6517-040-012	EUDAMED	Class IIa	Active
Tpx	7200-008-000	EUDAMED	Class IIa	Active
TPS Burs	7201-002-021	EUDAMED	Class IIa	Active
J-Notch Burs	6517-048-021	EUDAMED	Class IIa	Active
J-Notch Burs	6517-040-016	EUDAMED	Class IIa	Active
Tpx	7200-277-010	EUDAMED	Class I	Active
TPS Burs	7201-002-032	EUDAMED	Class IIa	Active
J-Notch Burs	6517-070-021	EUDAMED	Class IIa	Active
J-Notch Burs	6517-040-010	EUDAMED	Class IIa	Active
Hydro Irrigation System	K253679	FDA 510(k)	Class II	Active
Torque Wrench	5450-800-039	EUDAMEDFDA UDI	Class I	Active
Stryker Consolidated Operating Room Equipment (core) System	K032303	FDA 510(k)	Class II	Active
Stryker Painpump2	K030661	FDA 510(k)	Class II	Active
Neptune Waste Management Ststem	K012991	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Newgen System	K002619	FDA 510(k)	Class II	Active
Stereotactic Frame Based System	K003486	FDA 510(k)	Class II	Active
SpineJack® Expansion Kit	K223294	FDA 510(k)	Class II	Active
Stryker Navigation System - Cranial Module, Model 6000-650-000	K062640	FDA 510(k)	Class II	Active
SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement	K211238	FDA 510(k)	Class II	Active
Modification To Stryker Painpump	K031249	FDA 510(k)	Class II	Active
120V 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)	K222552	FDA 510(k)	Class II	Active
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R	K250374	FDA 510(k)	Class II	Active
System 9 Sterile Battery Container	K242834	FDA 510(k)	Class II	Active
Stryker Consolidated Operating Room Equipment (core) System	K040369	FDA 510(k)	Class II	Active
Neuro N100 Radiofrequency Generator And Accessory Cables	K010969	FDA 510(k)	Class II	Active
Stryker Total Performance (tps) System	K032117	FDA 510(k)	Class II	Active
Stryker Sagittal Saw Attachment	K954483	FDA 510(k)	Class I	Active
SurgiCount+ System	K232250	FDA 510(k)	Class II	Active
Stryker Interpulse Handpiece Set, Irrigation Tips, Splash Shields, Canal Vision Tip, Irrigation & Suction Tips	K951666	FDA 510(k)	Class II	Active
Hummer Iv Microdebrider System	K011381	FDA 510(k)	Class II	Active
Stryker Command2 Office Console	K953071	FDA 510(k)	Class I	Active
Stryker Navigation System - Ct-Based Hip Module, Model 6007-621-000	K050615	FDA 510(k)	Class II	Active
OptaBlate Radiofrequency (RF) Generator System	K250327	FDA 510(k)	Class II	Active
Stryker Universal Drill Attachments & Accessories	K962800	FDA 510(k)	Class I	Active
Stryker Navigation System - Hip Module	K022365	FDA 510(k)	Class II	Active
Stryker T4 Urethane Hood; Stryker T4 Urethane Zipper Toga; Stryker T4 Urethane Pullover Toga	K022162	FDA 510(k)	Class II	Active
Stryker T4 Hood, Stryker T4 Zippered Toga, Stryker T4 Pullover Toga	K993148	FDA 510(k)	Class II	Active
Stryker Interpulse Handpiece Set, Splash Shields, Irrigation And Suction Tips, Rechargeable Battery Pack	K972069	FDA 510(k)	Class II	Active
Stryker Hermes-Ready Total Performance System	K991703	FDA 510(k)	Class II	Active
Ivas 20mm (10 Gauge) Balloon Catheter	K113477	FDA 510(k)	Class II	Active
Stryker Stri-Shield Flyte Togas	K073017	FDA 510(k)	Class II	Active
Stryker Silverglide Bipolar Forceps Reusable Cable; Disposable Cable	K061835	FDA 510(k)	Class II	Active
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)	K243930	FDA 510(k)	U	Active
Stryker Consolidated Operating Room Equipment (core)	K040300	FDA 510(k)	Class II	Active
Stryker Integrated Bipolar Cord and Tubing Sets	K172367	FDA 510(k)	Class II	Active
Stryker System 4000 Heavy Duty Battery Powered Equipment	K972367	FDA 510(k)	Class I	Active
Modification To Stryker Painpump2	K030885	FDA 510(k)	Class II	Active
PhotonBlade 3; PhotonBlade 3 Smoke Evacuation	K242266	FDA 510(k)	Class II	Active
SurgiCount+ System	K252282	FDA 510(k)	Class II	Active
Stryker Navigation System-Spine & Fluoroscopy Modules	K003111	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

Stryker European Operations Limited IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 24, 2022	Z-1478-2022	—	open, classified	There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.
Jul 14, 2004	Z-0020-05	—	terminated	The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.
Jul 14, 2004	Z-0021-05	—	terminated	The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.
Nov 12, 2003	Z-0171-04	—	terminated	Product sterility may have been compromised by an inadequate package seal.
Jun 1, 2003	Z-0921-03	—	terminated	Non-sterilized product sold as sterile.
Dec 3, 2002	Z-0524-03	—	terminated	Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.