Stryker Tijuana Operations

Registration Details

Registration Name: Stryker Tijuana Operations
Registration Number: 3020163307
FEI Number: 3020163307
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: Ave. Todos los santos No. 10802 Col. Leandro Valle
City: Tijuana Baja California
Country: MX

Regulatory Submissions

510(k) Number: K141095

Owner / Operator

Firm Name: STRYKER CORP.
Operator Number: 1811755
Address: 4100 East Milham Ave.
City: Kalamazoo
State: MI
Postal Code: 49001
Country: US

US Agent

Business Name: Stryker
Contact Name: Shamaila Rafiq
Address: 325 Corporate Dr
City: Mahwah
State: NJ
ZIP: 07430
Country: US
Email: [email protected]
Phone: 201 3769049

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Gown, Surgical	FYA	Class 2	General, Plastic Surgery	No	2014-11-19
Device, Transfer, Patient, Manual	FMR	Class 1	General Hospital	No	2008-12-30
Hood, Surgical	FXY	Class 2	General, Plastic Surgery	No	2024-12-10
Monitor, Bed Patient	KMI	Class 1	General Hospital	No	2018-06-14
Mixer, Cement, For Clinical Use	JDZ	Class 1	Orthopedic	No	1995-03-14
Sleeve, Limb, Compressible	JOW	Class 2	Cardiovascular	No	2010-02-05
Oximeter, Reprocessed	NLF	Class 2	Cardiovascular	No	2010-02-05
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	NUJ	Class 2	General, Plastic Surgery	No	2018-01-09
Electrosurgical, Cutting & Coagulation & Accessories	GEI	Class 2	General, Plastic Surgery	No	2018-01-09
Non-Surgical Gown	OEA	Class 1	General, Plastic Surgery	No	2020-03-26
Oximeter	DQA	Class 2	Cardiovascular	No	2025-08-20
Cement, Bone, Vertebroplasty	NDN	Class 2	Orthopedic	No	2015-09-10
Bone Cement	LOD	Class 2	Orthopedic	No	2015-09-10
Cable, Electrode	IKD	Class 2	Physical Medicine	No	2013-09-25
Laparoscope, General & Plastic Surgery, Reprocessed	NLM	Class 2	Gastroenterology, Urology	No	2010-02-05
Tourniquet, Pneumatic	KCY	Class 1	General, Plastic Surgery	No	2007-06-20
Device, Patient Transfer, Powered	FRZ	Class 2	General Hospital	No	2018-06-14

Proprietary Names

Flyte SurgiCool Togas Device, Transfer, Patient Manual, Reprocessed Reprocessed Prevalon AirTAP Glide Sheet MIXER ACM PCD MIXEVAC CEMENT MIXERS AND KITS REVOLUTION AUTOPLEX AEQUALIS PERFORM Reprocessed Compression Sleeve Reprocessed Nellcor Pulse Oximeter Sensor Reprocessed Masimo Pulse Oximeter Sensor FLYTE HOODS Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Dividers Flyte SurgiCool Hoods Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider Non-sterile Flyte Hoods and Togas T7 Surgical Personal Protective Equipment Hoods and Togas Reprocessed RD Set Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider 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 CABLE, ELECTRODE Reprocessed Suture Passer Reprocessed Tourniquet Cuff Reprocessed RD SET Pulse Oximeter Sensor FLYTE TOGAS Reprocessed LigaSure Maryland Jaw Sealer/Divider

Establishment Types

Manufacture Medical Device Reprocess Single-Use Device Manufacture Medical Device for Another Party (Contract Manufacturer)