FDA Registration Active 🇺🇸 United States

Linvatec Corporation

Reg #: 1017294 · FEI: 1017294 · Expires 2026
Products
89
Proprietary Names
580
Establishment Types
5
Classifications
89

Registration Details

Registration Name
Linvatec Corporation
Registration Number
1017294
FEI Number
1017294
Status
Active
Expiry Year
2026
Initial Importer
No
Address
11311 Concept Boulevard
City
LARGO
State
FL
ZIP
33773
Country
US

Regulatory Submissions

510(k) Number
K063859

Owner / Operator

Firm Name
CONMED CORPORATION
Operator Number
1317214
Address
11311 Concept Boulevard, --
City
Largo
State
FL
Postal Code
33773
Country
US
Correspondent
Brent Lalomia

Products

Device Name Product Code
Laparoscope, General & Plastic Surgery GCJ
Staple, Fixation, Bone JDR
Arthroscope HRX
Electrosurgical, Cutting & Coagulation & Accessories GEI
Fastener, Fixation, Biodegradable, Soft Tissue MAI
Passer HWQ
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Camera, Surgical And Accessories KQM
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
Screw, Fixation, Bone HWC
Tubing, Pressure And Accessories BYX
Motor, Surgical Instrument, Pneumatic Powered GET
Laparoscope, Gynecologic (And Accessories) HET
Light, Surgical, Ceiling Mounted FSY
Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
Knife, Orthopedic HTS
Operating Room Accessories Table Tray FWZ
Fastener, Fixation, Nondegradable, Soft Tissue MBI
Saw, Pneumatically Powered KFK
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Tray, Surgical, Instrument FSM
Light Source, Fiberoptic, Routine FCW
Apparatus, Exhaust, Surgical FYD
Instrument, Cutting, Orthopedic HTZ
Template HWT
Suture, Nonabsorbable, Synthetic, Polyethylene GAT
Mesh, Surgical, Polymeric FTL
Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament QWJ
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon OWW
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon OWY
Screwdriver HXX
Washer, Bolt Nut HTN
Source, Carrier, Fiberoptic Light EQH
Kit, Surgical Instrument, Disposable KDD
Pin, Fixation, Smooth HTY
Suture, Nonabsorbable, Synthetic, Polyamide GAR
Suture, Nonabsorbable, Silk GAP
Suture, Nonabsorbable, Synthetic, Polypropylene GAW
Suture, Nonabsorbable, Synthetic, Polyester GAS
Blade, Saw, General & Plastic Surgery, Surgical GFA
Insufflator, Laparoscopic HIF
Accessories, Arthroscopic NBH
Rasp HTR
Syringe, Piston FMF
Tap, Bone HWX
Wrap, Sterilization FRG
Led Light Source NTN
Bur, Ear, Nose And Throat EQJ
Wrench HXC
Regulator, Pressure, Gas Cylinder CAN
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Catheter, Irrigation GBX
Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
Media, Electroconductive GYB
Bit, Surgical GFG
Gauge, Depth HTJ
Cannula, Surgical, General & Plastic Surgery GEA
Light Source, Endoscope, Xenon Arc GCT
Motor, Drill, Electric HBC
Instrument, Manual, Surgical, General Use MDM
Orthopedic Manual Surgical Instrument LXH
Hammer, Surgical FZY
Camera, Still, Endoscopic FXM
Esophagoscope, General & Plastic Surgery GCL
Electrode, Electrosurgical JOS
Saw, Powered, And Accessories HAB
Light, Examination, Medical, Battery Powered KYT
Light, Surgical, Fiberoptic FST
Holder, Camera, Surgical FXR
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
Motor, Surgical Instrument, Ac-Powered GEY
Probe HXB
Guide, Needle, Surgical GDF
Forceps, General & Plastic Surgery GEN
Cannula, Ophthalmic HMX
Mesh, Surgical, Deployer ORQ
Neurological Stereotaxic Instrument HAW
Needle, Suturing, Disposable GAB
Battery, Replacement, Rechargeable MOQ
Staple, Absorbable MNU
Drill, Bone, Powered DZI
Motor, Drill, Pneumatic HBB
Apparatus, Traction, Non-Powered HST
Clamp, Surgical, General & Plastic Surgery GDJ
Guide, Surgical, Instrument FZX
Tubing, Noninvasive GAZ
Snare, Surgical GAE
Reamer HTO
Bur, Surgical, General & Plastic Surgery GFF

Proprietary Names

AnchorPort Staplizer Drill Guide STAPLE PRY Punch Removal STAPLIZER CARTRIDGE STAPLIZER HANDPC STAPLER SEATER STAPLE CARRIER Trident Ablator 3CCD EYECUP HEAD Viking Resect Ablator Trident Excalibur PALADIN MINI -REVO DRIVER CONCEPT SUTURE PASSER FULL HEMISPHERICAL REAMER CONCEPT VIDEO IMAGING SYSTEM CEBOTOME BUR EXTENSION CEBOTOME REVISION DRILL CEBOTOME METAL CUTTING BUR REVO REMOVER MINI-REVO REMOVER AnchorPort SILK Ablator BIOSTINGER HOSE ASSEMBLY UNIVERSAL HOSE HOSE HANDLERS OSTEON HOSE NITROGEN HOSE iFS Cart with Valve and two Bottle Racks iFS House Gas Switching Valve Pin Index Yoke Mounted Valve iFS Cart 6" Bottle with Valve iFS Cart with Valve Valve with Hoses and Mounting Bracket Dual Tank Gauge ULTRAPOWER HI-SPEED DRILL OSTEON HANDPIECE ULTRAOWER DRILL W/O HOSE ULTRAOWER PERFORATOR DRIVE W/O HOSE NURSES'S ASSISTANT HIP PRESERVATION SYSTEM BANANA BLADE LIBERATOR KNIFE Universal Modular Cart Cord Wraps FIXATION STRAP STRESS POST LEG STABILIZER STABILIZER BALL Universal Cart Strap Universal Modular Base Cart ExoShape Bone Fixation 24K Shaver sensor 24K Irrigation 24K Tips Tubing Set HelixAR ABC System Y-KNOT RC ALL-SUTURE ANCHOR Sternum Saw guard Smartnail INTRUMENTS TRAY Genesys Matryx POWERPRO PNEUMATIC OSCILLATOR HANDPIECE POWERPRO HIGH SPEED DRILL ATTACHMENT CEBOTOME BUR EXTENSION, SHORT MICRO 100 FOOT CONTROL POWERPRO PNEUMATIC MODULAR HANDPIECE MICROMITE INSTRUMENT TRAY TUNNEL DILATOR GRAFIX GRAFT INSTRUMENT TRAY PINN ACL DROSSPIN E9000 BUR RACK UPPERARM STRAP MINI-REVO INSTRUMENT CASE BULLSEYE TRAY AUTOCLAVABLE TRAY INSTABILITY TRAY BIO INSTABILITY INTRUMENT TRAY ULTRAFIX INSTRUMENT TRAY RCR INSTRUMENT TRAY BIOANCHOR INSTRUMENT TRAY FOREARM STRAP Pinn-ACL TRAY XO BUTTON HOLDER CRUCIATE RECONST SHUTT MASTER SET TRACTION TOWER COOLING BIN ZONE SPECIFIC INSTRUMENT TRAY MENISCUS INSTRUMENT TRAY HALL MICROFREE HandStand ThRevo Anchor Linvatec Tube Set CHIP Camera MicroPower Sagittal Saw SmartGuard Irrigator GUARDSMAN INTERFERENCE SCREW PROPEL INTERFERENCE SCREW TUBING SET ENHANCE Allograft Wedge Instrumentation Tray Argo Knotless Genesys Anchors Y-Knot OneStep Anchor SnapEvac PlumePen PenAdapt CONMED CrystalView WIREDRIVER 100 CHUCK ADAPTOR WIREDRIVER WIRE GUARD REPEAT STERNOTOMY SAW MICRO 100 WIREDRIVER THROTTLE CLIP MICRO 100 DRILL MICRO 100 OSCILLATOR SAW MICRO 100 SAGITTAL SAW MICRO 100 RECIPROCATOR SAW BULLSEYE GRAFIX PREP TABLE GRAFT GUIDE BONE TUNNEL SIZER ZEN WIRELESS FOOTSWITCH BIO-ANCHOR BioBrace Reinforced BioInductive Implant BIOSCREW DRIVER MicroLink LIGHT GUIDE Y-KNOT FLEX PERCUTANEOUS PACK HIP ARTHROSCOPY Percutaneous Pack ACL DISPOSABLE KIT Pinn-ACL AirSeal MICROCHOICE FOOT CONTROL MICROCHOICE POLE MOUNT MICROCHOICE WIRE DRIVER DRILL MICROCHOICE BUR GUARD MICROCHOICE WIRE DRIVER MICROCHOICE PIN DRIVER MICROCHOICE UNIVERSAL DRILL Suture Loop Hi-Fi WIREDRIVER GUARD CONCEPT CANNULATED INTERFERENCE SCREW EZSTART MERLIN PREBENT STERLING CUDA GRAFT HARVESTING BLADE GRAFT HARVESTING BLD STERNOTOMY BLADE CONVEX RESECTOR RHINOTEC GATOR BENDABLE NEXGEN OSCILLATOR BLADE MERLIN GREAT WHITE MICRO SAGITTAL BLADE SAGITTAL SAW BLAD INTREX BLADE ULTRACUT REACT OSCILLATING BLADE FULL RADIUS RESECTOR STERLING REACT RECIPROCATOR BLADE OSCILLATOR BLADE ME-92 HALL BLADE OSCILLATING BLADE STRYKER SAGITTAL BLADE ULTRACUT PREBENT MICROCHOICE STERN BLADE HALL SAGITTAL BLADE STERLING GATOR PRIMECUT OSCILLATING BLADE STERNUM SAW BLADE REACT CUDA BLADE ULTRAGATOR SHAVER BLADE STERLING DRAGON HIP PRESERVATION SYSTEM STERLING GREAT WHITE STRYKER OSCILLATING SAW BLADE HIP PRESERVATION SYSTEM M-CLASS OSCILLATING SAW BLADES MERLING GREAT WHITE BENDABLE MERLIN GATOR HALL SERIES SAW BLADE VORTEX PRE BENT SPHERICAL BUR GATOR MENISCUS CUTTER MICRO OSCILLATOR BLADE LANZA 3DHD Stereoscope System ULTRAFIX Stitchpak ULTRAFIX APEX Tubing Set Gravity MICROCHOICE CONTROLLER MICROCHOICE SHAVER HANDPIECE GENESYS PRESSFT SUTURE ANCHOR GENESYS PRESSFT FLEX AIrseal Infinity AIM Zone Specific AIM SUPER REVO FLEXIBLE CANNULA BULLSEYE AIMER HEX FLEX CANNULA ZONE II CANNULA FENESTRATED CANNULA HIP PRESERVATION SYSTEM NEEDLE PACK SLOTTED CANNULA LOOPED KNOT PUSHER CONCEPT LINEAR GASPER PERCUTANEOUS PISTON BIO ANCHOR LOCATOR SMARTNAIL PERCUTANEOUS TIP STOPCOCK SHEATH EXTENDED LENGTH CANNULA MICROFRACTURE AWL MINI REVO BONE PUNCH BIO INSTABILITY BONE PUNCH CANNULATED OBTURATOR INFUSION ADAPTER ARTHRO SCOPES QUICKLATCH CONICAL OBTURATOR BLITZ SUTURE RETRIEVER Y-KNOT FLEX OBTURATOR STOPCOCK DOUBLELATCH BRIDGE DRY-DOC CANNULA RASP QUICK-CONNECT BLUNT OBTURATOR CANNUAL ADAPTER ALLIGATOR GRASPER ARTHOSCOPY SHEATH BODY PESSURE SENSING STOPCOCK SHEATH SET DUAL STOPCOCK PRESSURE SENSING ARC MicroPower Smartpin RASP LIBERATOR KNIFE ROTATOR RASP CIRCULAR RASP ConMed Mixing and Delivery Kit Irrigation Console 10K ENDURA VORTEX ENDURA GATOR ENDURA RESECTOR ENDURA CUDA ENDURA BUR E9000 Console Dispersive Electrode Adapters CROSSFT TAP PALADIN TAP MINI REVO TAP BIO INSTABILITY TAP BIOSCREW TAP ULTRAFIX TAP GENESYS MATRYX INTEREFERENCE SCREW TAP CrossFT CONMED Argo Knotless® Anchor HD Monitor 4K UHD Monitor Articulating Arm Mounting Brackets Looking Glass Shelf linvatec cable Genesys CrossFT SUTURE ANCHOR STERNUM SAW HANDPIECE BioBrace Extra-Articular Ligament Augmentation Kit Osteoprep Sterilization Tray ROTATOR STERILIZATION TRAY Spectrum Instrument Tray Double Armed Suture Needle Presto VP1005 Video Tray Single Level (RADEL) VP1003 Video Extended Length Tray (RADEL) VP1007 Video Laparoscope Tray (RADEL) VP1006 Video Arthroscope Tray (RADEL) Electronic Light Guide MERLIN CUDA BLADE RHINOTEC CUDA BLADE RHINOTEC OVAL BURR RHINOTEC MICROXCISOR PRESSFT PRESSFT FLEX Contour Meniscus Arrow Infinity GUARDMAN INTERFERENCE SCREW YKnot TruShot XO BUTTON GraftMax Button CrossFT Knotless ULTRAPOWER WRENCH ARTHROSCOPIC WRENCH CEBOTOME WRENCH NITROGEN TESTER NITROGEN REGULATOR NITROGEN CONNECTOR NITROGEN ADAPTER NITROGEN COUPLER OrthoVAC Big Yank Reusable Dispersive Electrode Reusable Pediatric Dispersive Electrode Reusable Grounding Pad Cables Micro IRRIGATION TUBING Bio Mini-Revo CrosFT Knotless 3DHD Video Cart, Coupler AirSeal Smoke Evac PLUS Aspen Gel SMARTPIN DRILL BIT Y-Knot BADGER CANNULATED POPLOK DRILL BIT REVO DRILL BIT Y-KNOT DRILL BIT IMPACT DRILL BIT SENTINEL DRILL BIT BADGER DRILL BIT SMARTPIN MIN-REVO DRILL BIT MICROMITE DRILL E9000 BUR SMARTNAIL ULTRAFIX DRILL Y-KNOT FLEX DRILL BIT MICROLINK INFINITY BIOANCHOR DRIVER E9000 Tubing set Lightwave Ablator DEPTH GUAGE EcoFlow 10k tubesets, 24k tubesets HSW Laparoscopy Set SurgiQuest Laparoscope Hall Sterilization Tray PowerPro Sterilization Case CANNUAL SHAFT CANNULA TIP CANNULA Grasper Core Light Source AirSeal iFS SUPER REVO SUTURE ANCHOR Osprey Drill BIO-STINGER-V Argo Knotless WIRED DRIVER BRUSH SHAVER BLADE DE-CLOGGER EZ STITCH, HOOK CONVEX RASP K-WIRED REVO BONE PUNCH ULTRAFIX DRILL GUIDE CTS RELIEF KIT CUFFED CURETTE BREAKAWAY PINS MENISCUS ARROW SUTURE PASSER INSTABILITY POPLOK DRILL GUIDE GRAFT TENSIONER CONCEPT GRASPER BIO-ANCHOR DRILL GUIDE EL BIO-INSTABILITY DRILL GUIDE BANANA KNIFE PINN ACL GUIDE FEMORAL GUIDE TIBIAL PIN GUIDE MINI- REVO THREADER CONCAVE RASP ARTHROSCOPY KNIFE, RETROGRADE RETRACTOR DRILL GUIDE OSTEOTOME MERLIN BENDER BULLSEYE GUIDE END PLUG CRORSSFT PUNCH CRESCENT HOOK REVO HOOK ACL CROSSPIN ROD MINI- REVO DRIVER CORTICAL GAUGE PUNCH FEMORAL FOOTPRINT GUIDE BIO-ANCHOR DRIVER SPECTRUM II ROLLER WHEE RAVEN SUTURE RETRIEVER SMARTPIN K-WIRE GUARDMAN GRAFT PROTECTOR SUPER REVO DRIVER KATANA SUTURE CUTTER HEX CANNULATED DRIVER POPLOK PUNCH ACL CROSSPIN DRIVER CONCEPT GRAFIX STRIPPER MICROMITE INSERTER Y-KNOT PUNCH GENESYS CROSSFT PUNCH REVO REMOVER MINI-REVO REMOVER MINI-REVO REMOVER GUIDE EXOSHAPE ARGO KNOTLESS GENESYS PUNCH ARTHROSCOPIC PISTON Y-KNOT FLEX ALL SUTURE ANCHOR Paradigm Surgical Camera Y-Knotless™ Flex Anchors Broncho UtraAblator BIOSCREW XTRALOK POWERPRO ATTACHMENT MPOWER2 HANDPIECE HALL 50 HANDPIECE POWERPRO BATTERY CHARGER PowerPro Console POWERPROMAX TWO TRIGGER POWERPRO REAMER ATTACHMENT TRANSFER BATTERY CASE HALL MICROFREE Power Pro Low Impact FLX-LITE HD EYECUP SCOPE HD CARTRIDGE SCOPE HD EYECUP CARTRIDGE LAPAROSCOPE HD EYECUP LAPAROSCOPE Y-KNOT ALL SUTURE ANCHOR MENISECTOMY ELECTRODE ELECTRODE HALL DRILL REAM ATTACHMENT POWERPRO UNIVERSAL CABLE POWERPROMAX DRIVER ATTACHMENT ADVANTAGE 2 PowerPro Attachments C-SERTER MICRO 100 TUBING 10K, Linvatec BioBrace Reinforced Implant True HD 3MOS Camera System EZStart Interference Screw 3DHD Light Guide BioCuff TISSUE GRASPER Camera Holder D4000A-Drive System with Irrigation D4000 Drive System Artho Power Console Artho Power Console with Irrigation Pump PROBE ASSEMBLY SMARTNAIL ARTHROSCOPIC PISTON PROBE SUPER REVO GUIDE DELUXE FORCEPS MOSQUITO GRASPER GRASPING FORCEPS STANDARD SCISSOR B-SCOOP FORCEPS RETROGRADE FORCEPS RECTRIVAL FORCEPS AGGRESOR FORCEPS SST FORCEPS MINI AGGRESSOR FORCEPS BLUNT FORCEPS MICRO SCISSOR Conmed Cannula Paradigm All Suture Anchor ABCFlex Flexible Endoscopy Probes System 7550 ABC ESU Tubing PowerPro BioBrace RC Delivery System Luxtec MICROCHOICE MINI DRIVER HANDPIECE MINOS HANDPIECE RETRACTOR GUARD SAGITTAL SAW Surgairtome II BUR GUARD UltraPower HALL SERIES 3 OSCILLATOR ELECTRODE BASIC KIT ACROMIOPLASTY ELECTRODE Electrode ELECTRODE KIT MENISCECTOMY ELECTRODE APEX TUBING SET MENISCAL REPAIR NEEDLES VERSIPOWER PLUS BATTERY HALL LITHIUM BATTERY POWERPRO BATTERY ULTRAFIX Minimite BIOSCREW INTERFERENCE SCREW BIOSCREW FEMORAL SCREW Advantage Console SEQUENT MENISCAL REPAIR Camera and Console BioBrace® Reinforced Implant REVO REVO SUTURE ANCHOR MINI-REVO SCREW TenoLok Dual Expanding Tenodesis Anchor TenoLok TenoLok Tenodesis Kits PowerPro Battery POWERPRO KEYLESS ATTACHMENT TRANSFER CHARGE PLATFORM POWERPRO TRANSFER BATTERY CASE POWERPRO BATTERY FILTER ULTRAFIX Micromite TruShot with Y-Knot PowerPro Pneumatic HD QUICKLATCH ARTHROSCOPE ARTHROSCOPE QUICKLATCH ARTHROSCOPE Camera Head Eyecup Looking Glass™ CUFFLINK SurgiQuest DuoPort DIGIT TRAP HOLDER PAD WEDGES RESTRAIN SET Replacement Bulb SmartNail HelixAR CLAMP Endoscopy Video Camera System INSTILLING NEEDLE Luxtec MLX Light Source RCA MINI PLUG SDI VIDEO CABLES USB PRINTER CABLE ENDOPEARL eLUma Linvatec light source Y-KNOT FLEX DRILL GUIDE Y-KNOT DRILL GUIDE Y-KNOT Surgairtome Two Handpiece Arthroscopy Cassette and Dual Spike core puddle vac Suture Snare SINGLE JAW GRASPER Endosite Digital C-Wire Disposable Bipolar Cable CONCEPT, GRAFIX FLAT WASHER Spiked Washer Cancellous Screw Cortical Screw FLEX GUIDE WIRE HYPERFLEX GUIDE WIRE hRevo-FT SUTURE ANCHOR Super RevoFT SUTURE ANCHOR PopLok Heatwave Electrode MICRO ROUND BUR MICRO DRIVER, MINOS BUR CEBOTOME BUR CRANIOPLATY BUR MICRO SIDE CUTTING VORTEX, MICROBLADE OSTEON BUR ROUND CUT CARBIDE BUR OVAL BUR MICRO MILL CUTTER Micro Straight Side Cutting Bur WIRE PASS DRILL ULTRAPOWER BUR SIDE CUT CARBIDE BUR STERLING OVAL BUR MICRO TAPERED FISSURE BUR CYLINDRICAL BUR STERLING VORTEX ULTRAGATOR MICRO RECIPRICATOR RASP BUR BRUSH DERMABRADER

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)