Stryker Tijuana Operations

FDA Device Registration & Listing · Tijuana Baja California, MX · Registration 3020163307

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
3020163307
FEI Number
3020163307
Entity Name
Stryker Tijuana Operations
City/State/Country
Tijuana Baja California, MX
Establishment Address
Ave. Todos los santos No. 10802 Col. Leandro Valle, Tijuana Baja California C.P. 22643, MX
Establishment Type(s)
Reprocess Single-Use Device
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

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 Nellcor Pulse Oximeter Sensor Reprocessed Compression Sleeve 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 Compression Sleeve 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2014-11-19
FMR Device, Transfer, Patient, Manual General Hospital Class 1 880.6785 2008-12-30
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2024-12-10
FXY Hood, Surgical General, Plastic Surgery Class 2 878.4040 2024-12-10
KMI Monitor, Bed Patient General Hospital Class 1 880.2400 2018-06-14
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 1995-03-14
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2010-02-05
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2010-02-05
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2010-02-05
FXY Hood, Surgical General, Plastic Surgery Class 2 878.4040 2007-11-29
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2007-11-29
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2022-04-11
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2010-12-06
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2018-01-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-01-09
FXY Hood, Surgical General, Plastic Surgery Class 2 878.4040 2014-07-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-04-20
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2018-04-20
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-03-26
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2020-03-23
FXY Hood, Surgical General, Plastic Surgery Class 2 878.4040 2020-03-23
DQA Oximeter Cardiovascular Class 2 870.2700 2025-08-20
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2025-08-20
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2010-02-05
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2023-04-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-04-11
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2015-09-10
LOD Bone Cement Orthopedic Class 2 888.3027 2015-09-10
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2013-09-25

Official Correspondent

No official correspondent registered.

US Agent Details

Shamaila Rafiq Business: Stryker Email: Shamaila.Rafiq@stryker.com Phone: (201) 3769049

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
K892118 Paramount Products, Inc. NON-STERILE MASKS AND CAPS 1989-04-20
K170216 Tactile Systems Technology, Inc. (Dba Tactile Medical) Flexitouch System 2017-05-26
K100306 Covidien KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES 2010-05-04
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-0001-06 VIASYS Med Systems 2
Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090
Z-0002-06 VIASYS Med Systems 2
Stackhouse Lens/Hood, Mark III Universal; a sterile disposable protective head garment for use with the Stackhouse Mark III Helmet, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090
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
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020163307. Last updated year: 2026. Please use registration number 3020163307 when referencing this establishment in official correspondence.
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