Stryker Sustainability Solutions

FDA Device Registration & Listing · Tempe, AZ, US · Registration 3009350690

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
3009350690
FEI Number
3009350690
Entity Name
Stryker Sustainability Solutions
City/State/Country
Tempe, AZ, US
Establishment Address
1810 W. Drake Dr., Tempe, AZ 85283, US
Establishment Type(s)
Reprocess Single-Use Device,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
N
Expiration Date (Year)
2026
510(k) Number
K100909
PMA Number
N/A

All Registered Proprietary Names

Reprocessed External Fixation Device Reprocessed EP Catheter Reprocessed Intravascular Ultrasound Catheter Reprocessed Hoffmann 3 External Fixation Devices Reprocessed EP Catheter Reprocessed Unipolar Laparoscopic/Endoscopic Instruments Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider Reprocessed External Fixation Device REPROCESSED STEERABLE INTRODUCER Remanufactured LigaSure Exact Dissector, Without Nano-coating Reprocessed Endoscopic Trocars and Sleeves Device, Transfer, Patient Manual, Reprocessed Reprocessed Prevalon AirTAP Glide Sheet Reprocessed External Fixation Device Reprocessed Compression Sleeve Reprocessed Trocars and Stability Sleeves Reprocessed Blunt Tip Laparoscopic Sealer/Divider Reprocessed Masimo Pulse Oximeter Sensor Reprocessed External Fixation Device Reprocessed EP Catheter and Cable Reprocessed EP Catheter and Cable Reprocessed RD Set Reprocessed Nellcor Pulse Oximeter Sensor Reprocessed Nellcor Pulse Oximeter Sensor Reprocessed EP Catheter Reprocessed Diagnostic Ultrasound Catheter Reprocessed External Fixation Device Reprocessed Compression Sleeve Reprocessed EP Catheter CABLE, ELECTRODE Reprocessed Nellcor Pulse Oximeter Sensor Reprocessed EP Catheter Reprocessed Unipolar Laparoscopic/Endoscopic Instruments Reprocessed Aquamantys Bipolar Sealer Reprocessed Laparoscopic Accessories Reprocessed External Fixation Device Reprocessed Electrophysiology Catheter Catheter, Recording, Electrode, Reprocessed Reprocessed RD SET Pulse Oximeter Sensor Reprocessed EP Catheter and Cable Reprocessed External Fixation Device Reprocessed Harmonic ACE Shears without adaptive tissue technology Reprocessed Arthroscopic Cutters Reprocessed LigaSure Maryland Jaw Sealer/Divider Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider Reprocessed External Fixation Device Reprocessed Compression Sleeve

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2010-02-05
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2010-02-05
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2010-02-05
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2010-02-05
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2010-02-05
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2016-04-13
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2016-04-13
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2016-04-13
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2010-02-05
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2020-01-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-05-27
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2022-05-27
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2010-02-05
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-04-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-05-27
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-08-07
NLM Laparoscope, General & Plastic Surgery, Reprocessed Gastroenterology, Urology Class 2 876.1500 2020-08-07
FMR Device, Transfer, Patient, Manual General Hospital Class 1 880.6785 2008-12-30
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2010-02-05
FRZ Device, Patient Transfer, Powered General Hospital Class 2 880.6775 2018-06-14
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2010-02-05
NLM Laparoscope, General & Plastic Surgery, Reprocessed Gastroenterology, Urology Class 2 876.1500 2014-01-06
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2014-04-23
DQA Oximeter Cardiovascular Class 2 870.2700 2022-04-11
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2010-02-05
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2010-02-05
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2010-02-05
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2010-02-05
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2010-02-05
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2010-02-05
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2010-02-05
DQA Oximeter Cardiovascular Class 2 870.2700 2025-08-20
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2025-08-20
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2022-04-11
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2010-02-05
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2010-02-05
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2010-02-05
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2010-02-05
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2010-02-05
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2010-02-05
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2010-02-05
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2010-07-23
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2013-09-25
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2010-02-05
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2010-02-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-01-17
KMI Monitor, Bed Patient General Hospital Class 1 880.2400 2018-06-14
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2025-11-18
NWV Laparoscopic Accessories, Gynecologic Obstetrics/Gynecology Class 1 884.1720 2016-05-10
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2010-02-05
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2010-02-05
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2012-11-12
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2020-05-14
DQA Oximeter Cardiovascular Class 2 870.2700 2022-12-09
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2022-12-09
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2010-02-05
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2010-02-05
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2010-02-05
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2010-02-05
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2010-02-05
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unknown Class U N/A 2014-05-02
HRX Arthroscope Orthopedic Class 2 888.1100 2010-02-05
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2018-05-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-07
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
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2010-02-05
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2010-02-05
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2010-02-05
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2010-12-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K893928 Buckman Co., Inc. LEVTECH SMALL BONE PLATE 1989-11-03
K033476 Howmedica Osteonics Corp. MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM 2004-01-20
K150357 Sterilmed, Inc. Reprocessed Electrophysiology Diagnostic Catheters 2015-08-27
K043393 Alliance Medical Corp. REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS 2005-03-23
K232130 Surgical Instrument Services and Savings, Inc. Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter 2023-12-15

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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-0783-2020 Abbott Medical 2
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020 Abbott Medical 2
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0027-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009350690. Last updated year: 2026. Please use registration number 3009350690 when referencing this establishment in official correspondence.
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