STRYKER MANUFACTURING KALAMAZOO

FDA Device Registration & Listing · Portage, MI, US · Registration 3007997036

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
3007997036
FEI Number
3007997036
Entity Name
STRYKER MANUFACTURING KALAMAZOO
City/State/Country
Portage, MI, US
Establishment Address
6201 South Sprinkle Road, Portage, MI 49002, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
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

SWEAT BANDS 24/PKG SWEAT BANDS 36/PKG FLYTE BATTERIES FLYTE CHARGER Pi Drive 2 Motor Pi Drive 2 Plus Motor Monopolar Return Electrode Cable MIXER ACM PCD MIXEVAC CEMENT MIXERS AND KITS REVOLUTION AUTOPLEX AEQUALIS PERFORM 4102-452 w/no feet on bottom sterilization case System 4000 mini sterilization case Battery Powered ScrewDriver II Battery Pack for VariSpeed Stryker VariSpeed BATTERY POWERED SCREWDRIVER II HUMMER IV 7.5MM Round FoCESS HD Wireless Camera System Stryker Maestro System FLYTE HELMETS T5 HELMETS Stryker Aria Pneumatic System STRYKER DRILL CORE System Stryker Maestro Air Motor Stryker Maestro Air Motor with Handswitch TPS Console TPS Standard Attachment Brush TPS Micro Drill/Elite Attachment Brush TPS Unidirectional Footswitch Stryker(R) Consolidated Operating Room Equipment (CORE) System 4cm Angled Irrigation Clip 4cm Straight Irrigation Clip RemB Micro Drill 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 SMOKE EVACUATION TUBING/WAND NEPTUNE WASTE MGMT(SMOKE EVACUATOR) 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) E-TYPE SPEED REDUCER CONTRA ANGLE Stryker CORE System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2002-09-16
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2016-04-28
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2016-04-28
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2022-12-12
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2021-06-18
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2021-06-18
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2021-06-18
DZI Drill, Bone, Powered Dental Class 2 872.4120 2019-06-28
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2017-05-30
GXD Generator, Lesion, Radiofrequency Neurology Class 2 882.4400 2017-05-30
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 1995-03-14
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2006-12-12
GEY Motor, Surgical Instrument, Ac-Powered General, Plastic Surgery Class 1 878.4820 2006-08-03
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2008-12-19
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2009-04-22
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2015-04-24
FWL Camera, Cine, Endoscopic, Without Audio General, Plastic Surgery Class 1 878.4160 2018-12-28
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2015-05-10
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2007-12-03
FXZ Helmet, Surgical General, Plastic Surgery Class 1 878.4040 1995-07-11
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2007-12-03
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2015-05-03
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2015-05-03
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2006-12-12
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2019-04-15
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2015-07-21
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2007-11-29
GEY Motor, Surgical Instrument, Ac-Powered General, Plastic Surgery Class 1 878.4820 2007-11-29
EIA Unit, Operative Dental Dental Class 1 872.6640 2007-11-29
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2007-11-29
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2007-11-29
DZI Drill, Bone, Powered Dental Class 2 872.4120 2007-11-29
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2007-11-29
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2014-07-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-08-29
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-07-26
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2024-07-26
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2024-07-26
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2024-07-26
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2006-12-12
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2007-11-29
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2014-01-29
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2014-01-29
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2024-01-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-17
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2024-06-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-06-17
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2024-06-17
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2007-12-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-09-29
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2024-05-09

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
K082762 Aardvark Medical AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE 2008-11-12
K964548 Linvatec Corp. APEX UNIVERSAL DRIVE SYSTEM 1997-01-17
K253907 ABBOTT MEDICAL Disposable Radiofrequency Cannula 2026-04-16
K242841 ABBOTT MEDICAL Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) 2025-05-27
K020354 Baylis Medical Co., Inc. BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) 2002-05-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0038-05 Kinetic Concepts, Inc 2
V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230
Z-0720-2020 Abbott Medical 2
CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.
Z-0664-2020 Abbott Medical 2
Radiofrequency Grounding Pad, REF RF-DGP-L
Z-0026-2026 Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany 2
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Z-0027-2026 Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany 2
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007997036. Last updated year: 2026. Please use registration number 3007997036 when referencing this establishment in official correspondence.
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