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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stirrups | EYD | Class 1 | Gastroenterology, Urology | No | 2024-06-03 |
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2013-11-21 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2017-12-14 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2010-06-08 |
| Surgical Table Cushion | LWG | Class 1 | General, Plastic Surgery | No | 2016-04-07 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2024-06-03 |
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2013-11-21 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2014-12-18 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 1992-12-26 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2014-12-18 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2022-04-21 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2022-04-21 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2022-04-21 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2006-01-18 |
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