STRYKER Communications, Inc.

FDA Device Registration & Listing · Flower Mound, TX, US · Registration 2031963

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
2031963
FEI Number
3002975342
Entity Name
STRYKER Communications, Inc.
City/State/Country
Flower Mound, TX, US
Establishment Address
571 Silveron Blvd., Flower Mound, TX 75028, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
STRYKER CORP. (Owner Number: 1811755)
Owner / Operator Contact Address
4100 East Milham Ave., Kalamazoo, MI 49001, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

K-TEK 250 STIRRUP WITH SECURE-LOK STRAPS KTEK KNEE CRUTCH, GOEPEL (PR) KTEK COMFORT 800 STIRRUP K-TEK COMFORT 350 STIRRUP Visum LED Surgical Light Non-Sterile URO DRAIN BAG Strykecam 2 In-Light Camera Strykecam HD In-Light Camera CHROMOVISION HD Cameras Strykecam HD for F-Gen Strykecam for F-Gen Strykecam for Visum LED P59109 StrykeCam 4K, In-Light Camera Surgical Table and Accessory Pads Chromophare Surgical Light System ACCEND Spring Arm, Classic, stop 12-21kg ACCEND DROP TUBE HARDWARE KIT ACCEND Suspension, L/FP, 1300/1200mm ACCEND Lighthead Electronics Repair ACCEND Ceiling Cover Hardware ACCEND Drop Tube, 350mm ACCEND Rotating Soffit Assembly ACCEND Suspension, L/L, 1300/1200mm ACCEND Drop Tube, 150 mm, M12 ACCEND Suspension Covers/Caps ACCEND Drop Tube, 400 mm, M12 ACCEND Ceiling Cover ACCEND SPRING ARM PACKAGING KIT ACCEND Light Classic, 1050mm ACCEND L/FP Classic, 1050/925mm ACCEND Spring Arm Hardware ACCEND Drop Tube, 150mm ACCEND FP/L/L Flat, 1400/1300/1200mm ACCEND Conduit Termination Plate ACCEND L/FP Flat, 1300/1200mm ACCEND Suspension, L/L, 1050/925mm ACCEND Suspension, L/FP, 1050/925mm ACCEND Flat Panel Hardware ACCEND Suspension, FP/L/L, 1200/1050/925mm ACCEND LIGHT HEAD PACKAGING KIT ACCEND Suspension, Light, 1050mm ACCEND FP/L/L Classic, 1200/1050/925mm ACCEND Spring Arm, Flat, no stop 12-21kg ACCEND Flat Panel Covers/Caps ACCEND L/FP Flat, 1050/925mm ACCEND Handle Adapter, Devon SlipOn ACCEND Handle Adapter, Sterilizable ACCEND Spring Arm Covers/Caps ACCEND Flat Panel Mount ACCEND Lighthead with Classic Cardanic ACCEND Power Supply ACCEND Spring Arm, Classic, no stop 12-21kg ACCEND L/L Flat, 1300/1200mm ACCEND Cardanic Control Repair ACCEND Handle Cover, Sterilizable ACCEND Cardanic Caps ACCEND Drop Tube, 250 mm, M12 ACCEND Suspension Hardware ACCEND LONG SUSPENSION PACKAGING KIT ACCEND Suspension, FP/L/L, 1400/1300/1200mm ACCEND Lighthead with Flat Cardanic ACCEND Handle Adapter, Devon ScrewOn ACCEND Drop Tube, 400mm ACCEND SUSPENSION PACKAGING KIT ACCEND L/L Classic, 1050/925mm ACCEND Light Flat, 1050mm K-TEK ATTACHMENT BAND FOR URO DRAINAGE BAGS, UNIVERSAL KTEK FLEXIBLE ANESTHESIA SCREEN K-TEK ARM PROTECTION SHIELD KTEK NISSEN STRAP (PR) KTEK SHOULDER SUPPORTS (PR) KTEK PATIENT SECURITY STRAP, PADDED, MEDIUM Flexis Boom System Single Universal Flat Panel Suspension Monitor Mount Monitor Ceiling Suspension (MCS) Boom System TELETOM Equipment Management System Light Duty Suspension Medium Duty Suspension Medium Duty Dual Yoke Navigation System Suspension Dual Flat Panel (FP) Yoke Suspension S-Series Equipment Management System HipCheck Table Mount Visum Blade LED Surgical Light System OPERON Accessories K-TEK CURVE SPINE FRAME K-TEK CLAMSHELL ARMBOARD PAD 3" K-TEK LATERAL POSITIONER, ROUND K-TEK SWIVEL ARMBOARD, SMALL K-TEK CURVE CRANK HANDLE K-TEK LATERAL POSITIONER, RECTANGLE K-TEK SWIVEL ARMBOARD, LARGE K-TEK COMFORT STANDARD ARMBOARD PAD, 2 3/8 K-TEK ARMBOARD, US OSTEONOICS Angeld Farabeuf clamp Farabeuf clamp Jaw Clamp, Overbite Counterclockwise Jungbluth Clamp, Wide Jaw Clamp, Underbite Counterclockwise, Jaw Clamp, Std, Long Counterclockwise Jaw Clamp, Curved Offs. Counterclockwise Jaw Clamp, Std Offset Counterclockwise Jaw Clamp, Std Short Counterclockwise Jungbluth Clamp, Narrow Spike Disk, Large Weber Clamp Narrow Spike Disk, Oval Jaw Clamp Std Long Weber Clamp Std Weber Clamp Assmmetrical Left Jaw Clamp Large offset Straight Jaw Clamp offset Underbite Jaw Clamp Large Offset Curved Weber Clamp Assmmetrical Right Jaw Clamp offset Overbite Weber Clamp Contoured Jaw Clamp Std Short AEQUALIS FRACTURE HLS UNI EVOLUTION CLAMP FOREFOOT SET AEQUALIS Aequalis" PerFORM Aequalis" Instrument SALTO XT AEQUALIS RESURFACING HEAD General Instruments Flex Shoulder System TORNIER - INSTRUMENT SALTO TALARIS HLS KNEETEC Aequalis" Fx2 Triathlon Monogram Instruments KTEK SELECT BLADE CLAMP, US K-TEK BASIC CLAMP, US K-TEK BASIC CLAMP, EU/UK KTEK ROUND POST CLAMP, US K-TEK SELECT BLADE CLAMP, EU OPERON Surgical Tables, OPERON, X-Ray Cassette Tray, Inside Rail Clamp, Imaging Extension Filler Plate and Pad Visum Halogen Surgical Light 0502-500-001 ThermaClear Main Module 0502-000-003 ThermaClear Spine

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EYD Stirrups Gastroenterology, Urology Class 1 876.4890 2024-06-03
FSY Light, Surgical, Ceiling Mounted General, Plastic Surgery Class 2 878.4580 2013-11-21
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2017-12-14
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2010-06-08
LWG Surgical Table Cushion General, Plastic Surgery Class 1 878.4950 2016-04-07
FSY Light, Surgical, Ceiling Mounted General, Plastic Surgery Class 2 878.4580 2014-12-18
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2024-06-03
FQO Table, Operating-Room, Ac-Powered General, Plastic Surgery Class 1 878.4960 2013-11-21
FSY Light, Surgical, Ceiling Mounted General, Plastic Surgery Class 2 878.4580 2014-05-02
CCX Support, Patient Position Anesthesiology Class 1 868.6820 2014-12-18
HXD Clamp General, Plastic Surgery Class 1 878.4800 1992-12-26
GDC Table, Operating-Room, Electrical General, Plastic Surgery Class 1 878.4960 2014-12-18
FSY Light, Surgical, Ceiling Mounted General, Plastic Surgery Class 2 878.4580 2013-11-21
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2022-04-21
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2022-04-21
HRX Arthroscope Orthopedic Class 2 888.1100 2022-04-21

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
K780666 Castle Co. DAYSTAR SELECTRA & SELECTRA/ORBITER 1978-04-27
K914369 Deroyal Industries, Inc. QUALTEX MAGNETIC INSTRUMENT DRAPE 1991-12-02
K812809 Abco Dealers, Inc. STERILE ADHERENT DRAPES 1981-11-06
K910084 Biocor Medical, Inc. SURGICAL DRAPE 1991-03-19
K812396 Northwest Surgical Concepts, Inc. ARTHRO-PREP REST 1981-11-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0028-2016 Resource Optimization & Innovation Llc 2
regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016 Resource Optimization & Innovation Llc 2
regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016 Resource Optimization & Innovation Llc 2
regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016 Resource Optimization & Innovation Llc 2
regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016 Resource Optimization & Innovation Llc 2
regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2031963. Last updated year: 2026. Please use registration number 2031963 when referencing this establishment in official correspondence.
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