FDA Registration Active 🇺🇸 United States

STRYKER Communications, Inc.

Reg #: 2031963 · FEI: 3002975342 · Expires 2026
Products
14
Proprietary Names
155
Establishment Types
3
Classifications
14

Registration Details

Registration Name
STRYKER Communications, Inc.
Registration Number
2031963
FEI Number
3002975342
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
571 Silveron Blvd.
City
Flower Mound
State
TX
ZIP
75028
Country
US

Regulatory Submissions

510(k) Number
K060802

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
Stirrups EYD
Light, Surgical, Ceiling Mounted FSY
Drape, Surgical, Antimicrobial KKX
Camera, Surgical And Accessories KQM
Surgical Table Cushion LWG
Table And Attachments, Operating-Room BWN
Table, Operating-Room, Ac-Powered FQO
Support, Patient Position CCX
Clamp HXD
Table, Operating-Room, Electrical GDC
Insufflator, Hysteroscopic HIG
Warmer, Thermal, Infusion Fluid LGZ
Arthroscope HRX
Device, Medical Examination, Ac Powered KZF

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 Visum 300 Exam Light Visum XBlade LED Exam Light CHROMOPHARE Examination Light FD 6103 – Sirca/ 32” FP CE 3863075 – Sirca Ceiling, Double Arm CG 3913275 – Sirca Wall, Double, Hardware CF 3893075 – Sirca Mobile US FD 6203 – Sirca/ UDM CE 3853075 – Sirca Ceiling, Single Arm CG 3913175 – Sirca Wall Double Outlet Plug FS 6000 – Sirca TC – Double Arm

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility