Stryker Instruments

FDA Device Registration & Listing · Portage, MI, US · Registration 3015967359

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
3015967359
FEI Number
3015967359
Entity Name
Stryker Instruments
City/State/Country
Portage, MI, US
Establishment Address
1941 Stryker Way, Portage, MI 49002, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
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

mild Device Kit ZipSeal 16 Surgical Skin Closure Kit; ZipSeal 24 Surgical Skin Closure Kit Aspiration Line Assembly NICO Specimen Preserver SMOKE EVACUATION TUBING/WAND NEPTUNE WASTE MGMT(SMOKE EVACUATOR) Entellus Medical Reinforced Anesthesia Needle 10 PC TRAY 2 PC TRAY 5 PC TRAY IDET ADAPTER XprESS Dilitation 12cm iQ Apex 360 12cm iQ Standard 10cm iQ Broad Knife 12cm iQ Serrated Large 12cm iQ Barracuda 12cm iQ Large 18cm iQ Apex Micro Claw SONOPET IQ CONSOLE 18cm iQ Micro Claw 12cm iQ Micro 12cm iQ 120 Claw 11cm iQ Knife 12cm iQ Micro Claw 12cm iQ Claw 20cm iQ Apex 360 11cm iQ Apex Knife 20cm iQ Standard TPS Console TPS Standard Attachment Brush TPS Micro Drill/Elite Attachment Brush TPS Unidirectional Footswitch Specimen Infusion Valve Stryker Smart Pump NPSeal NICO SecureHold NICO Myriad NOVUS: Myriad-LX NICO Myriad NOVUS Handpiece NICO Myriad NOVUS Console NICO Myriad NOVUS: Illumination Pack MiniFESS Light Seeker 4102-452 w/no feet on bottom sterilization case System 4000 mini sterilization case Cement Pusher PERCUTANEOUS CEMENT GUN Injector Transfer Tube ALIQUOT DELIVERY SYSTEM Syringe ACM CARTRIDGE & TIPs DUALSPEED CEMENT INJECTION GUN Friction Cement Gun STRYKER CEMENT INJECTOR DUAL SPEED INJECTION GUN REVOLUTION TIPS LATE INJECTION CEMENT GUN Revolution Cement Gun Specimen Collector with Filter Element Stryker Aria Pneumatic System 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) MIS 16 cm Straight Nose Tube Non-Footed Attachment 8cm Non-Footed Attachment 9cm Footed Attachment 25mm MIS 13 cm Curved Nose Tube Footed Attachment 12mm Rotating Footed Attachment 16mm Rotating Footed Attachment 12mm MIS 13 cm Angled Nose Tube Rotating Footed Attachment 25mm MIS 13 cm Straight Hooded Nose Tube MIS 13 cm Straight Nose Tube MIS 16 cm Angled Nose Tube MIS 16 cm Curved Nose Tube MIS 13 cm Modified Curved Nose Tube Footed Attachment 16mm MIS 16 cm Straight Hooded Nose Tube 4 mm ENT MicroDebrider JAGUAR BONE BIOPSY NEEDLES Total Performance System (TPS) QBL Software License SurgiCount+ QBL/EMR Application Pi Drive Plus Motor Pi Drive Extender XprESS ENT Dilation System TGS Guidewire STRYKER DISCMONITOR Battery Powered ScrewDriver II Battery Pack for VariSpeed Stryker VariSpeed BATTERY POWERED SCREWDRIVER II Stryker(R) Consolidated Operating Room Equipment (CORE) System 4cm Angled Irrigation Clip 4cm Straight Irrigation Clip RemB Micro Drill HII TRAY UPPER INSERT OBLONG DRILL GUIDE DIAMETER 2MM HOFFMANN LRF INSTRUMENTS AND IMPLANTS TRAY AEQ FRACT MESUREUR AMOVIB TRIAL ANCHORAGE PLP30171 AO/JACOBS QUICK RELEASE APEX CHUCK 4mm UNIVERSAL PIN-WIRE CASE 8mm SUBFIX TRIAL HOFFMANN LRF SPANNER WRENCH - 5 mm HOFFMANN LRF WIRE BOLT WRENCH BARREL REAMER ASSEMBLY STAND SILICONE MAT DRILL GUIDE BLOCK YLW MONOTUBE 2 HOLE Perc. Double Wire Guide AEQ IMPACTEUR DE PROTHESE SET SCREW FOR TIBIA AIMING BLOCK OMEGA+ PIN W/THREAD 2.8X230MM TRIAL ANCHORAGE PLP30202 LID FOR PLATE RACK - GENERIC BIOCOMPRESSION WRENCH 15mm TUBE SET ANCILLARY IMPLANT SUBTALAR 7mm SPANNER WRENCH Graft box body AEQ USA FANT CALO AEQ FRAC SUPPORT DE BRAS SMALL SWIVEL JOINT RACK FOR OPEN WEDGE PLATES (LEVEL 2) TRIAL ANCHORAGE PLP40220 HOFFMANN XPRESS SILICON THUMBWHEEL OMEGA PLUS HEX POWERBIT W/TRKLE END 3.5mm OMEGA PLUS DRILL GUIDE 3.2mm DIA-2mm COMPRESSION APEX TRAY LOWER INSERT MONOTUBE TRIAX YELLOW CASE INSTRUMENT TRAY BASE 4.5 SPS BENDING SLEEVE - SLOTTED STEEL TIGE FRACTURE N.M Graft box compression screw Pangea T-Handle Graft box wedge T-HANDLE STEM HOLDER HOFFMANN LRF UNIVERSAL COMPONENTS TRAY HII MICRO STORAGE CASE LID AXSOS SPARE SET SCREW/FEMUR AIMING BLOCK HII COMPACT STORAGE CASE UPPER INSERT LID FOR PLATE RACK - SPECIAL PLATES AO/JACOBS QUICK RELEASE APEX CHUCK 3mm HII MICRO STORAGE CASE LOWER INSERT 6mm PREDRILL ASSEMBLY EXTRA SHORT 5mm PREDRILL ASSEMBLY EXTRA SHORT AEQ TIGE FRA LG FANT HOFFMANN XPRESS STORAGE CASE LID HII MICRO STORAGE CASE DRILL BIT HOLDER OMEGA PLUS DRILL GUIDE HANDLE HOFFMANN LRF UNIVERSAL COMPONENTS INSERT 6mm PREDRILL ASSEMBLY LONG RACK FOR PLP UTILITY/MTP (LEVEL 2) OMEGA PLUS TAP GUIDE 4.5mm APEX TRAY BASE INTERMEDIATE PROSTHESIS HOLDER LEFT HOWMEDICA MIX KIT I TM 10PK Graft sizer M/T TRIAX LNG HANDLE WRENCH BLUE TRIAL ANCHORAGE PLP40160 ANCHORAGE PLATE BENDER ANCHORAGE FIXATION PIN T-HANDLE PIN INSERTER HII COMPACT 5mm WRENCH/3&4mm SOCKET OMEGA PLUS SUPRACONDYLAR PIN GUIDE A 5 T-WRENCH TRIAL ANCHORAGE PLP30201 HII MICRO DRILL GUIDE ASSEMBLY HII COMPACT STORAGE CASE LID HOFFMANN LRF RATCHET WRENCH - HEX 10 HOFFMANN3 TRAY FOR STANDARD COMPOMENTS 4mm PREDRILL ASSEMBLY EXTRA SHORT HOFFMANN XPRESS TORQUE WRENCH 3mm PREDRILL ASSEMBLY SHORT DRILL GUIDE LOCK II 2.5 TRIAL ANCHORAGE PLP40400 HII TRAY LID HOFFMANN XPRESS STORAGE CASE INSERT M/T TRIAX LNG HANDLE WRENCH RED TRIAL ANCHORAGE PLP11341 HOLDING SPANNER 4.5 HII TRAY BASE HII MICRO NUT DRIVER MILITARY EXTERNAL FIXATION CASE 9mm SUBFIX TRIAL DEPTH GAUGE (DISTAL RADIUS) TRIAL ANCHORAGE PLP30142 DRILL GUIDE BLOCK COMPACT PERI 4 HOLE OMEGA+ VAR ANGLE GUID REPL KIT TRIAL ANCHORAGE PLP40280 DEPTH GAUGE (HAND) APEX DRILL BRACE - 3/4/5/6mm SUBFIX INSERTION INSTRUMENT TRIAL ANCHORAGE PLP30172 HII MRI TRAY LOWER INSERT CYLINDRICAL BUSH HOLDER 4mm PREDRILL ASSEMBLY SHORT Depth Gauge (Foot/Elbow/Distal Fib) ANCHORAGE PLATE GRIPPER HM MINI 4 SPANNER WRENCH 3mm PREDRILL ASSEMBLY LONG HII MRI TRAY BASE 10mm SUBFIX TRIAL DRILL GUIDE BLOCK MONOTUBE 4 HOLE DRILL GUIDE BLOCK HII 10 HOLE OMEGA PLUS TAP GUIDE 6.5mm ANCHORAGE CP MTP TEMPLATE HII 7mm T-WRENCH / 5+6mm SOCKET DJD II STORAGE CASE DRILL GUIDE BLOCK HII 5 HOLE 3MM DBL SLEEVE 80MM TROC/ASSY HOFFMANN LRF TELES. STRUT WRENCH SCREW CADDY FOR 2 / 2.5 FIXO TRAY ANCHORAGE CP POLYAXIAL DRILL GUIDE ANCHORAGE CP LAPIDUS TEMPLATE DEPTH GAUGE 4MM DBL SLVE 180MM TROC/ASSY STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2MM STANDARD BENDING SLEEVE TRAY HOFFMANN LRF WIRE TENS. NOSE - SHORT AO/JACOBS QUICK RELEASE APEX CHUCK 5mm INSTRUMENT TRAY LID FIXOS HOFFMANN XPRESS STORAGE CASE BASE TRAY FOR MV SCREWS 4mm PREDRILL ASSEMBLY LONG ANCHORAGE CP LAPIDUS PIVOTING DRILL GUIDE SMALL RULER FOR MEASUREMNET SCREW TRAY 4.5 TRIAL ANCHORAGE PLP10462 APEX TRAY LID 5mm PREDRILL ASSEMBLY LONG HII MICRO 2mm PIN DRIVER CUTTING SCREWDRIVER 4.5 EASY CLIP ANGLED DRILL GUIDE SIZE 15 UniVise Restoration ADM/MDM Instrumentation Accolade II System Instrumentation OMEGA PLUS TRIAL PLATE 150 Orthopaedic Manual Instrumentation Meniscal Transplant Set Exeter Hip System Instrumentation ACL Workstation Anato Hip System Instrumentation Biosteon Wedge Interference Screw System SCREW RACK WS + CS (2MM+3.5MM) Universal ACL Instrumentation SPIKE SCREW INSERTER FOR 4.5MM SCREWS OMEGA PLUS 145 DRILL GUIDE INSERT Overdrill for 4.5mm Screws, AO TwinLoop Anchor System LITe BIO Delivery System - Sterilization Tray and Lid Reduction Tray Insert for Jaw Clamps Reduction Tray Insert for Weber Clamps Silicon Mat, Insert for Jaw Clamps Reduction Tray Silicon Mat, Insert for Weber Clamps Silicon Mat, Generic Insert Reduction Tray generic Insert Colored Plugs Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest Stanmore Face Cutter and Alignment Tool BriteField Depth Gauge Mesa, Mesa Small Stature, Napa MI, Nile Alternative, Nile, Pyrenees, Santorini Terra Nova, Ravine, Serengeti, VCR, Cricket Trocar DISPOSABLE CEMENT SCULPS Counterbore Drill Tissue Protection Sleeve 206-716 w/2 small sculps/pkg Drill Sleeve AxSOS 3 Ankle Fusion AxSOS 3 Ti Posterior TLIF INTRAMEDULLARY BRUSH STANDARD 14MM OD Screwdriver Blade, AO, T10 Guide Wire Pusher Guide Wire Ruler STRAIGHT FEMORAL CANAL BRUSH Guide Wire, Threaded Guide Wire Targeter - Crown ORTHOPEDIC MANUAL Tray - Silicon Mat Bone Plug Extractor Guide Wire Targeter - Sleeve screw depth gauge Guide Wire Targeter Intraosseous Fixation system manual surgical instruments All Tornier Orthopeadic Manual Surgical Instruments (exempt) FEMORAL CANAL BRUSH, STANDARD General Instruments Edgelock manual surgical instruments AO Quick Coupling with Elastosil Handle Solid Screwdriver with AO Fitting Drill Bit ø 2,0 x 150mm Opening Reamer CalcLock manual surgical instruments Asnis® PRO Cannulated Screw System All OrthoHelix Orthopedic Manual Surgical Instruments Tornier Extraction Mini MaxLock manual surgical instruments Cannulated Screwdriver with AO Fitting Lag Screw Sleeve MaxLock Extreme manual surgical instruments Twist-drill cannulated ø8/L300mm Large AO Coupling - Hall Fitting set screw driver Threaded Guide Wire Screw Holder precision sleeve Cannulated Drill with AO Fitting Screw Insertion Sleeve Asnis® III Cannulated Screw System Guide Wire Insertion Sleeve for Guide Wire extraction shaft Multiple Drill Guide lag screw driver Drill Bit Cannulated Screwdriver with Elastosil Handle precision pin Opening Sleeve VariAx 2, Screw Rack Locking Screws VariAx 2, Screwdriver Blade VariAx 2, Inlay Holding Sleeve VariAx, Safety Shield Double Drill Guide ø 2,0/3,5mm Elastosil T-Handle with AO Coupling Opening Guide Extractor for Screws Cannulated Drill ø 2,7/3.5mm with AO Fitting Quick Release Driver Hall Fitting VariAx, Drill Guide Percutaneous guide wire inserter Cannulated Countersink with AO Fitting Tray insert Direct Measuring Gauge Stylet VariAx 2, Clip VariAx 2 Foot, Instrument Kit Parallel Guide for ø 1,4mm/2mm Wires tray base Cannulated Tap with AO Fitting Hoffmann LRF System, Wrench VariAx 2 foot, Depth Gauge lag screw reamer VariAx 2 Compression Plating System, Plate Insert AxSOS Variax 2, Steinmann Pin VariAx 2, Pliers Bixcut, IM Reamer Hoffmann LRF System, Wire Tensioner VariAx 2, Drill Guide K-Wire T2 Alpha Femur Retrograde Nailing System, Nail Adapter SPI VariAx, Tension Sheath VariAx 2, Insert VariAx, Handle VariAx 2, Drill Bit Anatomic Express Tray Hoffmann LRF System, Insert AxSOS 3 AF System and AxSOS 3 Ti System, Plate VariAx 2 Foot, Module Lid Hoffmann LRF System, Ruler VariAx 2, Distal Radius Implant Module VariAx, Screwdriver VariAx 2, Distal Radius Container Half-Size Hoffmann LRF System, Instrument VariAx 2, Screw Rack Non-Locking Screws VariAx 2, Handle With Drill Guides Dual-sided Baseplate Centering Guide T2 Alpha Femur Retrograde Nailing System, Nail Holding Screw SPI VariAx 2 Foot, Insert Stryker Trauma Pelvic Set (Matta) VariAX 2, Lid For Sterilizing Container VariAx 2, Depth Gauge VariAx Foot, Countersink VariAx 2 Foot, Tap for 2.7mm screws Extractor Rod PRO Plating System VariAx 2 Compression Plating System, Plate Trial VariAx 2, ScrewDriver Blade Modular Humeral Head Trial Post ATP Disc Prep Express Humeral Stem Extractor VariAx 2, Tap For 2.7mm Screws VariAx 2, Reduction Instrument Insert Modular Glenoid Surface Trial T2 Alpha Femur Retrograde Nailing System, Target Device NAPA Access System VariAx, Trial VariAx 2 Foot, Labeling Clip Express Insert VariAx 2, Joystick VariAx 2 Foot, Drawer VariAx 2, Fixed Angle Drill Guide 2.3/2.7mm PeriPROTM Femur VariAx, Tension Plier VariAx 2, Aiming Block Fixation Pin VariAx 2 Foot, Screw Rack VariAx 2, Handle With 2.3mm Drill And K-Wire Guide VariAx, Drill VariAx, Screw Length Marker AxSOS 3 Cascadia Interbody System Humeral Express Tray CURSOR Broach and Inserter Handle Modular Humeral Head Trial AEQ FRACT GR AXE LIAISON JA FANTOME CALOTTE T2 Alpha Femur Retrograde Nailing System, Tissue Protection Sleeve Graft box locking screw PROTRACTOR VariAx Foot, Holding Sleeve VariAx 2, Screw Rack INTERMEDIATE PROSTHESIS HOLDER RIGHT Variable Angle Fixation VariAx 2 Foot, Module Reverse Express Tray Pangea Platform Graft box washer 5mm SPANNER WRENCH HII COMPACT STORAGE CASE BASE SCREW RACK ANCHORAGE SPARE SET SCREW HUMERUS TS AIMING BLOCK 5mm PREDRILL ASSEMBLY SHORT TRIAL ANCHORAGE PLP30141 HOFFMANN LRF THUMBWHEEL - HEX 10 HII COMPACT MRI STORAGE CASE UPPER INSERT TRIAL ANCHORAGE PLP10342 HII TRAY LOWER INSERT OMEGA PLUS HEAD AO/JACOBS QUICK RELEASE APEX CHUCK 6mm TRIAL ANCHORAGE PLP40460 OMEGA PLUS LAG SCREW ADAPTER STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2.5MM PIN CUTTER / HA PINS 6.5mm SUBFIX TRIAL A 51 T WRENCH W/35 EXTENSION ANCHORAGE INSTRUMENTS RACK COVER HII MICRO STORAGE CASE BASE BIOCOMPRESSION WRENCH 25mm TUBE APEX TRAY UPPER INSERT SCREW-HOLDING FORCEPS FIXOS HOFFMANN XPRESS SILICON MAT GUIDE FOR HALF-PINS LID FOR INSTRUMENT TRAY ANCHORAGE INSTRUMENTS RACK (LEVEL 2) APEX DRILL GUIDE HANDLE HII COMPACT MRI STORAGE CASE BASE TENSION DEVICE 16MM OMEGA PLUS DRILL GUIDE 3.6mm DIA-NEUTRAL HII COMPACT GUIDE BLOCK W/AO REPLACEMENT KNOB FOR DRILL BRACE DRILL GUIDE BLOCK COMPACT 4 HOLE RACK FOR UTILITY/LISFRANC PLATES (LEVEL 2) KW BENDING IRON ICS Plastic Tray HOFFMANN LRF WIRE TENSIONER HII MICRO STORAGE CASE UPPER INSERT 4mm DBL SLEEVE 150mm TROC/ASSY REDUCTION HANDLES B & R CLAMPS M/T TRIAX LNG HANDLE WRENCH YELLOW A 4 4MM CHUCK HII COMPACT MRI STORAGE CASE LID TRIAL ANCHORAGE PLP40340 6mm PREDRILL ASSEMBLY SHORT PEDIATRIC CORTICAL REAMER HII MRI TRAY LID INCLINED DRILL GUIDE SCREW EZ18 ANCHORAGE INSTRUMENTS RACK (LEVEL 1) 11.5mm SUBFIX TRIAL SMART TOE 1 INSTRUMENT KIT HOFFMANN LRF INSTRUMENTS AND IMPLANTS INSERT ANCHORAGE FIXED DRILL GUIDE 2.5MM AO HANDLE - LENGTH 135MM AGM 6 6MM CHUCK TRIAL ANCHORAGE PLP10461 BIOCOMPRESSION WRENCH 20mm TUBE FIXOS 4 MV DEPTH GAUGE ANCHORAGE CP INSTRUMENTS SILICONE SUPPORT (WITHOUT INSTRUMENTS) OMEGA PLUS SUPRACONDYLAR DRILL GUIDE LID FOR PLATE RACK - COMPRESSION PLATES AXSOS ADAPTOR FOR TORQUE TESTER T8/T15 INCLINED DRILLING GUIDE + SCREW EZ20 TRIAL ANCHORAGE PLP11342 REPLACEMENT COMPONENTS A 2 DRILL BRACE W/O CHUCK RED & BLUE INTL M/T CASE HOFFMANN LRF SPANNER WRENCH - 7/10 mm TRIAL ANCHORAGE PLP10341 RING DRIVER 4.5 OMEGA PLUS DRILL GUIDE 3.6mm DIA-COMPRESSION HOFFMANN LRF THUMBWHEEL FOR TELESCOPIC STRUTS OMEGA PLUS SCREW EXTRACTION BOLT AEQ FRACT NM FANT TIG SPARE SHAFT TEMP. PLATE HOLDER SET SCREW FOR HUMERUS AIMING BLOCK PLATE BENDING IRONS HOFFMANN LRF WIRE TENS. NOSE - LONG AXSOS ADAPTOR FOR TORQUE TESTER T20 HOFFMANN XPRESS SPANNER WRENCH 7MM SPANNER WRENCH OMEGA PLUS DRILL GUIDE 3.2mm DIA-1mm COMPRESSION ANCHORAGE CP MTP PIVOTING DRILL GUIDE ANCHORAGE CP UTILITY TEMPLATE HOFFMANN LRF INFO BOARD OMEGA+ BARREL REAM ASSY SHORT ANCHORAGE FIXED DRILL GUIDE 2MM UNIVERSAL BENDING SLEEVE AEQ FRAC LONG SUP IMP ENS IRRIGATION HUMMER IV Bioprep Cement Restrictor MIXER ACM PCD MIXEVAC CEMENT MIXERS AND KITS REVOLUTION AUTOPLEX AEQUALIS PERFORM STERI-SHIELD SYSTEM FLYTE HOODS Myriad SPECTRA LightSource Myriad Illumination Pack Stryker Maestro Air Motor Stryker Maestro Air Motor with Handswitch RAVINE Access System Trays CANYON Retractor Systems Trays EVEREST Spinal System Trays Triathlon System Instrument trays Navigated Spine Instruments Trays DENALI Spinal System Trays CHESAPEAKE Stabilization System Trays Cascadia Interbody System Navigation Instruments Trays Stryker Orthopaedics Instrument Trays YUKON OCT Spinal System Trays PYRENEES Cervical Plate System Trays NAPA Access System Tornier Q Pedicle Instruments Aequalis Reversed II Eikon LT Sterilization Tray CAYMAN Plate System Trays Tornier Perform Anatomic Glenoid Aequalis Fracture Aequalis Reversed Fracture CASPIAN Spinal System Trays ATP Disc Prep Pangea Platform CAPRI Corpectomy Cage System Trays INBONE Eikon LT SL Sterilization Tray MESA Spinal System Trays Restoration Modular Instrument Trays ALEUTIAN Interbody Systems Trays OZARK Cervical Plate System Trays Tornier Pyrocarbon Aluminum Lid - Universal Triathlon MSI Tray SAHARA Stabilization System Trays Sterilization Box, Lightweight Hoffmann LRF Tornier Flex Shoulder System Universal Neuro III Accessory Tray Mako Instrument Trays Office Sinus Procedure Pack Pi Drive 2 Motor Pi Drive 2 Plus Motor Cyclone Sinonasal Suction and Irrigation System SurgiCount Tablet and accessories CAST SPREADERS (VARIOUS SIZES) VARIOUS SIZES OF CAST SPREA XprESS ENT Dilation System PreLoc 2 Wound Closure Device SUCTION MAT Suction Mat, Comfort,50"X34" WALL SUCTION KIT - CBC STRYKER SUCTION IRRIGATOR Neptune Bronze SUCTION RING WITH TUBING Strykevac SUCTION RING WITHOUT TUBING 0250-070-500 Suction Irrigator 2 0250-070-520 StrykeFlow 2 With Tip SUCTION RING SUCTION MAT,LOW PROFILE50"X34" Kirschner Wire 5MM FLEXIBLE REAMER 6MM FLEXIBLE REAMER 11MM FLEXIBLE REAMER 7.5MM FLEXIBLE REAMER 4.5MM FLEXIBLE REAMER 7MM FLEXIBLE REAMER 12MM FLEXIBLE REAMER 11.5MM FLEXIBLE REAMER 8MM FLEXIBLE REAMER 6.5MM FLEXIBLE REAMER 9.5MM FLEXIBLE REAMER FLEXIBLE GUIDE PIN VERSITOMIC STERILE FLEXIBLE PIN 10MM FLEXIBLE REAMER 5.5MM FLEXIBLE REAMER 8.5MM FLEXIBLE REAMER 9MM FLEXIBLE REAMER 10.5MM FLEXIBLE REAMER AEQUALIS REVERSED BIT General Surgical Bits STAINLESS STEEL INSERTER ACM system with cancellous FEMORAL SPONGE PKG 6 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 Fluid Safe 3000CC Canister Constavac and Battery Charger CONSTA VAC BLOOD CO TGS Universal Headrest with Mounting Arm Reusable Bipolar Forceps Cable Disposable Bipolar Forceps Cable Monopolar Return Electrode Cable Flyte SurgiCool Togas FLYTE TOGAS Non-sterile Flyte Hoods and Togas LITe BIO Delivery System - Loading Tool LITe BIO Delivery System - Loading Funnel MANUAL SURGICAL INSTRUMENTS WIRE CADDY General Instruments PRECISION DOWEL BONE GRAFT SYSTEM Instruments for Coverloc Volar Plat BrainPath Manipulation Tool T4/T5 HYTREL TOGAS T7 Surgical Personal Protective Equipment Hoods and Togas 95 mm Stylet ORTHOVAC CASTVAC XprESS Multi-Sinus Dilation System INTERPULSE SURGILAV STRYKER DRILL CORE System FoCESS HD Wireless Camera System mild Device Kit Flyte SurgiCool Hoods NICO Fluid System Stryker Maestro System Audion ET dilation system IV Pole THC5 Stand TPS2 Stand Infusion Stand MS -00017 MOLLI Pole Clamp Hydro Pole Mount Latera Absorbable Nasal Implant System T4/T5 HYTREL TOGA HANDPIECE STERILIZATION CASE SYSTEM STERILIZATION BASKET Total Performance System Hydro Disposable Irrigation Cassette Hydro Irrigation Console Hydro Foot Switch E-TYPE SPEED REDUCER CONTRA ANGLE Stryker CORE System TGS Field Generator Stand OmniCurve 11G –15 mm Balloon Kit OmniCurve 11G –20 mm Extra Level Kit OmniCurve 11G –30 mm Balloon Kit OmniCurve 10G- 15mm Extra Level OmniCurve 11G –20 mm Balloon Kit OmniCurve 11G –30 mm Extra Level Kit OmniCurve 10G- 20mm Extra Level OmniCurve 11G –15 mm Extra Level Kit OmniCurve 10G- 20mm Fracture Kit OmniCurve 10G- 15mm Fracture Kit OmniCurve 10G- 30mm Fracture Kit OmniCurve 10G- 30mm Extra Level XeroGel Nasal/Epistaxis Pack Cross-Screw System Meniscal Transplant Set Inter-Lock System TAMP General Instruments Aequalis" PerFORM OptaBlate Radiofrequency (RF) Generator Triton QBL System; Acaia Pearl Scale Bone Biopsy Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2024-05-09
HRX Arthroscope Orthopedic Class 2 888.1100 2024-10-18
MCY Wound Dressing Kit General Hospital Class 2 880.5075 2020-01-15
PBZ Image Processing Device For Estimation Of External Blood Loss General Hospital Class 2 880.2750 2021-10-25
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2024-10-18
JRR Regulator, Temperature Clinical Chemistry Class 1 862.2050 2024-10-18
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
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2022-12-12
DZI Drill, Bone, Powered Dental Class 2 872.4120 2019-06-28
PBZ Image Processing Device For Estimation Of External Blood Loss General Hospital Class 2 880.2750 2021-10-25
FYD Apparatus, Exhaust, Surgical General, Plastic Surgery Class 2 878.5070 2007-11-29
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2010-04-16
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2018-11-29
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2018-02-27
BYZ Trap, Sterile Specimen General Hospital Class 2 880.6740 2005-02-04
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2021-07-08
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2021-07-08
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2006-12-12
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2008-12-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-05-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-11-19
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2018-12-28
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
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2022-02-17
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
SFQ Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision General, Plastic Surgery Class 2 878.4400 2025-09-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-09-24
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2024-10-18
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2018-01-30
HRX Arthroscope Orthopedic Class 2 888.1100 2018-01-30
KCY Tourniquet, Pneumatic General, Plastic Surgery Class 1 878.5910 1989-09-27
GFE Brush, Dermabrasion, Powered General, Plastic Surgery Class 1 878.4820 1995-07-11
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2002-02-20
HRX Arthroscope Orthopedic Class 2 888.1100 2007-12-03
OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus General, Plastic Surgery Class 2 878.4683 2025-09-09
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 1992-12-26
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-04-22
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2020-04-22
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2020-04-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2020-04-22
OAR Injector, Vertebroplasty (Does Not Contain Cement) Orthopedic Class 1 888.4200 2016-05-05
HXG Tamp Orthopedic Class 1 888.4540 2016-05-05
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2016-05-05
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1992-12-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-04-16
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2024-10-18
HBI Illuminator, Fiberoptic, Surgical Field General, Plastic Surgery Class 2 878.4580 2024-10-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-10-18
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2024-10-18
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2024-10-18
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2019-03-19
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2006-12-12
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2000-06-09
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2024-10-18
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2007-12-03
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
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2017-02-21
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2019-06-28
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2019-06-28
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 1996-02-06
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2007-12-03
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2007-11-29
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2021-07-27
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2015-12-03
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2018-12-28
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2020-04-17
FMF Syringe, Piston General Hospital Class 2 880.5860 2002-02-20
GEY Motor, Surgical Instrument, Ac-Powered General, Plastic Surgery Class 1 878.4820 2006-08-03
PBZ Image Processing Device For Estimation Of External Blood Loss General Hospital Class 2 880.2750 2024-02-05
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2014-07-17
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2003-12-22
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 1992-12-26
HBF Drills, Burrs, Trephines & Accessories (Compound, Powered) Neurology Class 2 882.4305 2009-04-30
EJL Bur, Dental Dental Class 1 872.3240 1992-12-22
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2009-04-22
LZN Cement Obturator General, Plastic Surgery Class 2 878.3300 1997-02-07
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 1995-03-14
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2009-04-27
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2023-05-22
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
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2013-06-03
HRX Arthroscope Orthopedic Class 2 888.1100 2013-06-03
QFX Diagnostic Neurosurgical Microscope Filter Neurology Class 2 882.4950 2024-10-18
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2015-07-21
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1992-12-29
MMO Tray, Surgical, Ent Ear, Nose, Throat Class 1 874.4420 2018-12-28
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
PBZ Image Processing Device For Estimation Of External Blood Loss General Hospital Class 2 880.2750 2021-10-25
GBP Catheter, Multiple Lumen General, Plastic Surgery Class 1 878.4200 2018-12-28
OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus General, Plastic Surgery Class 2 878.4683 2025-09-11
LWH Counter, Sponge, Surgical General Hospital Class 1 880.2740 2017-02-14
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2014-12-08
LGG Instrument, Cast Application/Removal, Manual Orthopedic Class 1 888.5980 1995-07-11
HRX Arthroscope Orthopedic Class 2 888.1100 2017-07-20
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2017-07-20
OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus General, Plastic Surgery Class 2 878.4683 2025-09-11
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2018-12-28
PNZ Eustachian Tube Balloon Dilation Device Ear, Nose, Throat Class 2 874.4180 2018-12-28
OAR Injector, Vertebroplasty (Does Not Contain Cement) Orthopedic Class 1 888.4200 2008-11-19
MKY System, Skin Closure General, Plastic Surgery Class 1 878.4320 2020-01-15
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2000-09-12
LOD Bone Cement Orthopedic Class 2 888.3027 2000-09-12
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2013-08-09
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
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-02-08
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2000-01-24
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2011-11-28
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2023-02-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-01-08
GFG Bit, Surgical General, Plastic Surgery Class 1 878.4820 1995-07-11
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-06
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-09-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-11-09
LZN Cement Obturator General, Plastic Surgery Class 2 878.3300 2006-01-13
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2006-01-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-08-29
OCJ Spinal Channeling Instrument, Vertebroplasty Orthopedic Class 1 888.4540 2011-12-13
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2006-12-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-06-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-05-09
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 1995-07-11
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2020-04-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-29
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2017-05-30
GXD Generator, Lesion, Radiofrequency Neurology Class 2 882.4400 2017-05-30
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2025-05-19
HRX Arthroscope Orthopedic Class 2 888.1100 2018-12-21
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2018-12-21
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
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2014-11-19
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2009-04-24
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-03-26
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2005-04-26
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2009-04-27
FXY Hood, Surgical General, Plastic Surgery Class 2 878.4040 2009-04-27
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2017-09-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-05-09
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2022-01-17
LOD Bone Cement Orthopedic Class 2 888.3027 2022-01-17
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2022-01-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-09-06
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2020-03-23
FXY Hood, Surgical General, Plastic Surgery Class 2 878.4040 2020-03-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-04-18
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1977-12-29
LGH Instrument, Cast Removal, Ac-Powered Orthopedic Class 1 888.5960 2006-12-12
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2018-12-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-04-04
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-04-04
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2025-04-04
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2025-04-04
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2013-08-08
FQH Lavage, Jet General Hospital Class 2 880.5475 1995-03-14
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2006-12-12
FWL Camera, Cine, Endoscopic, Without Audio General, Plastic Surgery Class 1 878.4160 2018-12-28
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
HRX Arthroscope Orthopedic Class 2 888.1100 2024-10-18
HAE Rongeur, Manual Neurology Class 2 882.4840 2024-10-18
FXY Hood, Surgical General, Plastic Surgery Class 2 878.4040 2014-07-18
QGI Air-Handling Apparatus Accessory General, Plastic Surgery Class 1 878.5080 2019-08-22
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 1996-04-16
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2007-12-03
PNZ Eustachian Tube Balloon Dilation Device Ear, Nose, Throat Class 2 874.4180 2022-04-26
FOX Stand, Infusion General Hospital Class 1 880.6990 1992-12-15
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2023-02-02
NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable Ear, Nose, Throat Class 2 874.3620 2018-11-29
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2009-04-27
MOQ Battery, Replacement, Rechargeable General, Plastic Surgery Class 1 878.4820 2022-06-02
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2008-12-02
GWG Endoscope, Neurological Neurology Class 2 882.1480 2026-05-26
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2026-05-26
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2026-05-26
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2007-12-17
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2019-02-11
QLV Field Generator Positioning Device Neurology Class 1 882.4565 2021-12-22
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2017-03-01
HRX Arthroscope Orthopedic Class 2 888.1100 2017-03-01
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2018-12-28
EMX Balloon, Epistaxis Ear, Nose, Throat Class 1 874.4100 2018-12-28
HXG Tamp Orthopedic Class 1 888.4540 1995-05-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-09-19
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2015-03-11
MRL Scale, Sponge, Surgical, Electrically-Powered General Hospital Class 1 880.2740 2021-10-25
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-05-09
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2014-09-08
OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus General, Plastic Surgery Class 2 878.4683 2025-09-11

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
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13
K140696 Pioneer Surgical Technology, Inc. STREAMLINE TL SPINAL FIXATION SYSTEM 2014-04-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

Similar Registrations

Registration Number Establishment Name Location
3014725904 Medtronic Medical Costa Rica S.R.L. Coyol Alajuela, CR
3040335671 Stryker Ireland Ltd. Instruments Division, Innovation Centre Carrigtwohill Cork (County), IE
3010363503 FRUEH VERPACKUNGSTECHNIK AG Fehraltorf Zurich, CH
3010287737 BAECHLER FEINTECH AG Hoelstein Basel-Landschaft, CH
3010673850 MK medical GmbH Emmingen-Liptingen Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015967359. Last updated year: 2026. Please use registration number 3015967359 when referencing this establishment in official correspondence.
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