Stryker US Supply Chain Operations

FDA Device Registration & Listing · Plainfield, IN, US · Registration 3012497308

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
3012497308
FEI Number
3012497308
Entity Name
Stryker US Supply Chain Operations
City/State/Country
Plainfield, IN, US
Establishment Address
1551 Perry Rd Ste 101, Plainfield, IN 46168, US
Establishment Type(s)
Repack or Relabel Medical 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
K241272
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2016-01-20
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-04-30
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2012-04-30
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 2015-01-08
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2016-01-20
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2020-07-15
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2020-07-15
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2019-03-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-05-16
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2022-12-12
FXZ Helmet, Surgical General, Plastic Surgery Class 1 878.4040 1995-07-11
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-01-21
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2021-11-30
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
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2006-12-12
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2018-04-16
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2018-04-16
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2016-01-20
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2013-01-24
FQH Lavage, Jet General Hospital Class 2 880.5475 1995-03-14
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-01-21
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

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
K033736 Concentric Medical, Inc. MERCI RETRIEVER, MODELS 90065, 90066 2004-08-11
K043580 Chestnut Medical Technologies, Inc. ALLIGATOR RETRIEVAL DEVICE (ARD) 2005-03-24
K982883 Medtronics Interventional Vascular MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER 1998-09-04
K132420 Reflow Medical WINGMAN EXTENDABLE TIP SUPPORT CATHETER 2013-09-19
K082339 Endocross, Ltd. ENABLER-P SUPPORT CATHETER 2008-11-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04 Bard Peripheral Vascular 2
Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012497308. Last updated year: 2026. Please use registration number 3012497308 when referencing this establishment in official correspondence.
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