Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1017294

FEI Number

1017294

Entity Name

Linvatec Corporation

City/State/Country

LARGO, FL, US

Establishment Address

11311 Concept Boulevard, LARGO, FL 33773, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CONMED CORPORATION (Owner Number: 1317214)

Owner / Operator Contact Address

11311 Concept Boulevard, --, Largo, FL 33773, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K013131

PMA Number

N/A

All Registered 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 Viking 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 MICRO 100 WIREDRIVER MICRO 100 SAGITTAL SAW WIREDRIVER GUARD MICRO 100 OSCILLATOR SAW PROPEL INTERFERENCE SCREW CONCEPT CANNULATED INTERFERENCE SCREW GUARDSMAN 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 CHIP Camera SUPER REVO Genesys Matryx 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 AirSeal MERLIN CUDA BLADE RHINOTEC CUDA BLADE RHINOTEC OVAL BURR RHINOTEC MICROXCISOR ThRevo Anchor PRESSFT PRESSFT FLEX Contour Meniscus Arrow Infinity PROPEL INTERFERENCE SCREW 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 ExoShape 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 Pinn-ACL 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 AirSeal SUPER REVO SUTURE ANCHOR Osprey Drill BIO-STINGER-V CrossFT 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 BLITZ SUTURE RETRIEVER EL BIO-INSTABILITY DRILL GUIDE MICROMITE DRILL BANANA KNIFE PINN ACL GUIDE FEMORAL GUIDE TIBIAL PIN GUIDE MINI- REVO THREADER BULLSEYE AIMER CONCAVE RASP ARTHROSCOPY KNIFE, RETROGRADE RETRACTOR DRILL GUIDE OSTEOTOME MERLIN BENDER BULLSEYE GUIDE END PLUG CRORSSFT PUNCH BIOSCREW DRIVER 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 MICROFRACTURE AWL KATANA SUTURE CUTTER ULTRAFIX DRILL 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 Infinity AIM 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 BIOANCHOR DRIVER BioBrace Reinforced Implant True HD 3MOS Camera System EZStart Interference Screw HandStand 3DHD Light Guide ULTRAFIX 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 STABILIZER BALL SUPER REVO GUIDE DELUXE FORCEPS MOSQUITO GRASPER GRASPING FORCEPS STANDARD SCISSOR B-SCOOP FORCEPS RETROGRADE FORCEPS RECTRIVAL FORCEPS ALLIGATOR GRASPER 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 Resect Ablator Trident Tubing PowerPro BioBrace RC Delivery System Genesys Matryx Luxtec MICROCHOICE MINI DRIVER HANDPIECE MINOS HANDPIECE RETRACTOR GUARD SAGITTAL SAW Surgairtome II BUR GUARD UltraPower HALL SERIES 3 OSCILLATOR Smartpin ELECTRODE BASIC KIT ACROMIOPLASTY ELECTRODE Electrode ELECTRODE KIT MENISCECTOMY ELECTRODE BIOSCREW XTRALOK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-02-15
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-07-08
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-07-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-07-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-07-07
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-09-27
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-07-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-11-25
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2014-07-10
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2014-07-08
HWQ	Passer	Orthopedic	Class 1	888.4540	2014-07-10
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2014-07-08
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2014-07-08
HSZ	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2014-07-08
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-07-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-02-15
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-07-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-07-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-07-07
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	1992-07-22
GET	Motor, Surgical Instrument, Pneumatic Powered	General, Plastic Surgery	Class 1	878.4820	2014-07-09
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2014-07-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-07-11
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2014-07-11
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2014-07-11
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2014-07-11
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2014-07-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-07-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-07-23
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2011-02-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-01-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-07-09
KFK	Saw, Pneumatically Powered	General, Plastic Surgery	Class 1	878.4820	2014-07-10
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-07-23
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2014-07-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-07-23
HSZ	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2023-11-20
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-07-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-07-08
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2011-02-25
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2014-01-24
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-07-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-07-07
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-07-08
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2016-08-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-03-28
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-03-28
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-01-24
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2014-01-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-05-17
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2023-05-17
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2018-12-19
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2023-11-20
HWT	Template	Orthopedic	Class 1	888.4800	2014-07-10
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-07-08
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2014-07-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-07-08
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2014-07-08
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-04-08
QWJ	Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament	General, Plastic Surgery	Class 2	878.3300	2025-04-08
OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2025-04-08
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2025-04-08
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2014-07-11
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2019-07-01
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2014-07-11
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2014-07-10
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2014-07-07
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-02-15
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2014-07-08
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2015-05-07
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2015-05-07
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2015-05-07
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2015-05-07
GAS	Suture, Nonabsorbable, Synthetic, Polyester	General, Plastic Surgery	Class 2	878.5000	2015-05-07
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2014-07-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-07-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-07-07
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2014-07-10
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2014-01-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-07-08
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2011-02-25
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-07-08
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2014-07-09
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2018-04-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-04-23
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-05-18
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-05-18
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2014-01-24
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2014-07-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-07-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-07-23
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2014-07-11
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-07-08
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2013-07-23
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2014-07-11
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-05-07
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-02-25
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2011-02-25
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-07-08
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2014-07-08
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2011-02-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-03-03
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2014-07-11
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-12-02
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-12-02
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2011-05-16
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2014-07-08
KFK	Saw, Pneumatically Powered	General, Plastic Surgery	Class 1	878.4820	2014-07-09
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-11-21
OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2025-11-21
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2025-11-21
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2014-07-08
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-01-11
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2014-07-08
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2014-04-17
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2024-02-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-02-15
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2014-07-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-07-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-07-09
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-07-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-07-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-07-07
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-12-20
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-07-08
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2014-07-08
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2017-03-20
HXC	Wrench	Orthopedic	Class 1	888.4540	2014-07-11
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2014-07-10
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	1997-09-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-03-03
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2013-09-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-07-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-24
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2014-07-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-07-08
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-07-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-01-04
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2014-01-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-02-15
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2016-02-15
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2016-08-19
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2013-10-29
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2011-03-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-07-10
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2014-07-11
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2011-02-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-01-24
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2014-07-08
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-01-08
GCT	Light Source, Endoscope, Xenon Arc	Gastroenterology, Urology	Class 2	876.1500	2011-10-25
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2016-02-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-02-15
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2014-07-09
GAS	Suture, Nonabsorbable, Synthetic, Polyester	General, Plastic Surgery	Class 2	878.5000	2014-07-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-07-09
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2015-02-04
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2014-07-08
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2014-07-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2017-02-07
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1992-08-26
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2014-07-11
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-07-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-07-09
FXM	Camera, Still, Endoscopic	General, Plastic Surgery	Class 1	878.4160	2014-01-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2026-01-30
GCL	Esophagoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2005-08-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-07-08
JOS	Electrode, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2014-07-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-07-07
HAB	Saw, Powered, And Accessories	General, Plastic Surgery	Class 1	878.4820	2011-02-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-12-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-12-01
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2014-07-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-07-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-07-09
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-07-08
JOS	Electrode, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2014-07-08
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2011-02-25
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2014-07-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-07-08
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2024-06-20
OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2024-06-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-11-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-01-22
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2020-12-21
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2014-01-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-07-08
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2014-07-09
FXR	Holder, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2014-01-24
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2013-05-31
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2013-05-31
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2013-05-31
HXB	Probe	Orthopedic	Class 1	888.4540	2014-07-11
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-07-11
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2014-07-11
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-09-27
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-03-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-04-21
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-07-08
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2011-02-25
OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2025-04-08
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2025-04-08
ORQ	Mesh, Surgical, Deployer	General, Plastic Surgery	Class 2	878.3300	2025-04-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-07-23
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-07-23
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2014-01-24
GET	Motor, Surgical Instrument, Pneumatic Powered	General, Plastic Surgery	Class 1	878.4820	2014-07-11
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2013-07-23
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2014-07-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-07-07

Official Correspondent

Brent Lalomia

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CONMED CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3019101334	ConMed Corporation	New Haven, CT, US
3007305485	Consolidated Medical Equipment Company	Chihuahua, MX
1320894	CONMED CORPORATION	Utica, NY, US
1223925	Conmed Corporation	WESTBOROUGH, MA, US
3004491689	ConMed Corporation	Greenwood Village, CO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0008-2023	Synthes (USA) Products LLC	2	Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1017294. Last updated year: 2026. Please use registration number 1017294 when referencing this establishment in official correspondence.