FDA Registration
Active
🇺🇸 United States
Stryker US Supply Chain Operations
Reg #: 3012497308
·
FEI: 3012497308
·
Expires 2026
Products
17
Proprietary Names
60
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- Stryker US Supply Chain Operations
- Registration Number
- 3012497308
- FEI Number
- 3012497308
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1551 Perry Rd Ste 101
- City
- Plainfield
- State
- IN
- ZIP
- 46168
- Country
- US
Regulatory Submissions
- 510(k) Number
- K132641
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2016-01-20 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2012-04-30 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2012-04-30 |
| Hood, Surgical | FXY | Class 2 | General, Plastic Surgery | No | 2014-07-18 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2015-01-08 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2020-07-15 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2017-05-16 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | Class 2 | General, Plastic Surgery | No | 2022-12-12 |
| Helmet, Surgical | FXZ | Class 1 | General, Plastic Surgery | No | 1995-07-11 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2007-11-29 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2006-12-12 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2016-01-20 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2013-01-24 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 1995-03-14 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 1995-03-14 |
| Apparatus, Exhaust, Surgical | FYD | Class 2 | General, Plastic Surgery | No | 2014-01-29 |
| Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment | POL | Class 2 | Neurology | No | 2020-03-27 |
Proprietary Names
Trevo XP ProVue Retriever, 3x20mm Trevo XP ProVue Retriever, 4x20mm
Excelsior XT-27 Microcatheter
Flyte SurgiCool Hoods
Trevo XP ProVue Retriever, 4x30mm
AXS Vecta 71 Intermediate Catheter
AXS Vecta 74 Intermediate Catheter
AXS Universal Aspiration System (AXS Catalyst 7 Distal Access Catheter)
Guidewire with ICE Hydrophilic Coating
FLYTE HELMETS
T5 HELMETS
Echo Intracranial Base Catheter
AXS Vecta 46 Intermediate Catheter
FLYTE HOODS
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
AXS Catalyst Distal Access Catheter
Trevo Pro 18 Microcatheter
TransForm Super Compliant Occlusion Balloon Catheter
TransForm Compliant Occlusion Balloon Catheter
INTERPULSE
SURGILAV
Broadway 8 Catheter
MIXER
ACM
PCD
MIXEVAC CEMENT MIXERS AND KITS
REVOLUTION
AUTOPLEX
AEQUALIS PERFORM
Neptune 2 Rover (120V)
Neptune 2 Single-Port Manifold
Smoke Evacuator ULPA Filter
Neptune 2 4-Port Manifold
Neptune 2 Specimen Collection 4-Port Manifold
Neptune 2 Docking Station (120V)
Neptune 2 Docking Station (230V)
Fluid Suction HEPA Filter
Neptune 2 Rover (230V)
Smoke (Evacuator) Tubing, 3/8 inch x 10 feet
Smoke (Evacuator) Tubing, 7/8 inch x 10 feet
Neptune Smart Docking Station (120V)
T7 Surgical Personal Protective Equipment Hoods and Togas
Trevo NXT ProVue Retriever
Trevo Trak 21 Microcatheter
Establishment Types
Repack or Relabel Medical Device