BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gyrus ACMI, Inc.

    Reg #: 3011050570 · FEI: 3011050570 · Expires 2026
    View on FDA
    Products
    157
    Proprietary Names
    734
    Establishment Types
    6
    Classifications
    157

    Registration Details

    Registration Name
    Gyrus ACMI, Inc.
    Registration Number
    3011050570
    FEI Number
    3011050570
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9600 Louisiana Ave North
    City
    Brooklyn Park
    State
    MN
    ZIP
    55445
    Country
    US

    Regulatory Submissions

    510(k) Number
    K982734
    PMA Number
    P870076

    Owner / Operator

    Firm Name
    OLYMPUS CORPORATION
    Operator Number
    9067818
    Address
    2951 ISHIKAWA-CHO
    City
    HACHIOJI-SHI
    State
    Tokyo
    Postal Code
    192-8507
    Country
    JP

    Products

    Device Name Product Code
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Needle, Aspiration And Injection, Reusable GDM
    Tube, Tympanostomy ETD
    Insufflator, Hysteroscopic HIG
    Forceps HTD
    Powered Laser Surgical Instrument GEX
    Mold, Middle-Ear ETC
    Replacement, Ossicular Prosthesis, Total ETA
    Dissector, Tonsil KBM
    Prosthesis, Partial Ossicular Replacement ETB
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Enteroscope And Accessories FDA
    Light Source, Fiberoptic, Routine FCW
    Light Source, Endoscope, Xenon Arc GCT
    Image, Illumination, Fiberoptic, For Endoscope FFS
    Light Source, Photographic, Fiberoptic FCR
    Stent, Ureteral FAD
    Resectoscope, Working Element FDC
    Cystourethroscope FBO
    Knife, Ear JYO
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Instrument, Ent Manual Surgical LRC
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Dilator, Catheter, Ureteral EZN
    Dilator, Urethral KOE
    Bronchoscope (Flexible Or Rigid) EOQ
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Kit, Nephroscope FGA
    Forceps, Biopsy, Electric KGE
    Transducer, Ultrasonic, Diagnostic ITX
    Gastroscope And Accessories, Flexible/Rigid FDS
    Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) KHJ
    Forceps, Biopsy, Non-Electric FCL
    Snare, Flexible FDI
    Tubing, Noninvasive GAZ
    Needle, Aspiration And Injection, Disposable GAA
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Unit, Cautery, Thermal, Battery-Powered HQP
    Hysteroscope (And Accessories) HIH
    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
    Laparoscope, General & Plastic Surgery GCJ
    Electrocautery, Gynecologic (And Accessories) HGI
    Ligator, Esophageal MND
    Container, Specimen, Non-Sterile NNI
    Ring Cutter FNS
    Electrode, Electrosurgical, Active, Urological FAS
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Endoscope, Rigid GCM
    Bur, Ear, Nose And Throat EQJ
    Led Light Source NTN
    Tray, Surgical, Instrument FSM
    Lithotriptor, Electro-Hydraulic FFK
    Laparoscopic Accessories, Gynecologic NWV
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Laparoscopic Contraceptive Tubal Occlusion Device KNH
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Catheter, Ureteral, Gastro-Urology EYB
    Set, Audiometer Calibration EWA
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Lithotriptor, Ultrasonic FEO
    Accessories, Catheter, G-U KNY
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Catheter And Tip, Suction JOL
    Endoscopic Cytology Brush FDX
    Duodenoscope And Accessories, Flexible/Rigid FDT
    Colonoscope And Accessories, Flexible/Rigid FDF
    Gauge, Measuring JYJ
    Culdoscope (And Accessories) HEW
    Accessories, Cleaning Brushes, For Endoscope MNL
    Saw, Nasal KBC
    Lithotriptor, Biliary Mechanical LQC
    Balloon, Epistaxis EMX
    Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) HIN
    Endoscopic Storage Cover OCU
    Transilluminator, Fiber Optic MQW
    Speculum, Ent EPY
    Syringe, Balloon Inflation MAV
    Bronchoscope Accessory KTI
    Forceps, General & Plastic Surgery GEN
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Endoscope, Accessories, Narrow Band Spectrum NWB
    Choledochoscope And Accessories, Flexible/Rigid FBN
    Syringe, Irrigating (Non Dental) KYZ
    System, X-Ray, Fluoroscopic, Non-Image-Intensified JAB
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
    Rasp HTR
    Rongeur, Nasal KBB
    Prosthesis, Nose, Internal FZE
    Support, Head, Surgical, Ent EPW
    Catheter, Suprapubic (And Accessories) KOB
    Electrode, Electrosurgical JOS
    Arthroscope HRX
    Light, Surgical, Instrument FSQ
    Light, Surgical, Fiberoptic FST
    Splint, Intranasal Septal LYA
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Resectoscope FJL
    Bone Grafting Material, Synthetic LYC
    Camera, Surgical And Accessories KQM
    Laparoscope, Gynecologic (And Accessories) HET
    Dislodger, Stone, Flexible FGO
    System, Abortion, Vacuum HHI
    Curette, Suction, Endometrial (And Accessories) HHK
    Cement, Ear, Nose And Throat NEA
    Catheter, Nephrostomy LJE
    Mallet HXL
    Biopsy Needle FCG
    Prosthesis, Ear, Internal FZD
    Endoscope Channel Accessory ODC
    Endoscopic Irrigation/Suction System OCX
    Dilator, Esophageal KNQ
    System, Imaging, Gastrointestinal, Wireless, Capsule NEZ
    Instrument, Manual, Surgical, General Use MDM
    Evacuator, Gastro-Urology KQT
    Applicator, Ent KCJ
    System, Vocal Cord Medialization MIX
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Extractor, Vacuum, Fetal HDB
    Coagulator, Culdoscopic (And Accessories) HFI
    Stimulator, Nerve ETN
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Inserter, Myringotomy Tube JYM
    Stylet, Ureteral EYA
    Containment System, Laparoscopic Power Morcellation, With Instrument Port PMU
    Urethrotome EZO
    Coagulator, Laparoscopic, Unipolar (And Accessories) HFG
    Tube, Ear Suction JZF
    Instrument, Ultrasonic Surgical LFL
    Curette, Nasal KAP
    Forceps, Wire Closure, Ent, Sterile JXX
    Colposcope (And Colpomicroscope), Exempt PTZ
    Endoscopic Central Control Unit ODA
    Laryngoscope, Rigid CCW
    Display, Cathode-Ray Tube, Medical DXJ
    Illuminator, Fiberoptic, Surgical Field HBI
    Neurological Stereotaxic Instrument HAW
    Ear Wick KCN
    Material, Impression ELW
    Hemostatic Metal Clip For The Gi Tract PKL
    Mediastinoscope, Surgical EWY
    Gauze / Sponge,Nonresorbable For External Use NAB
    Wire, Guide, Catheter DQX
    Mirror, Headband, Ophthalmic HKF
    Accessories, Cleaning, For Endoscope FEB
    Curette, Ear JYG
    System, X-Ray, Tomography, Computed JAK
    Stripper, Artery, Intraluminal DWX
    Cannula, Sinus KAM
    Gastrointesinal Lesion Software Detection System QNP
    Splint, Nasal EPP
    Perforator, Ear-Lobe JYS
    Staple, Implantable GDW
    Hook, Microsurgical Ear JYL

    Proprietary Names

    Ultrasil Sheehy-Type Collar Button Armstrong Bevelled Grommet Ultrasil Paparella Paparella Ultrasil Ultasil Richards T Tube Ultrasil Shepared Grommet Dolphin Collection Set Clip applier Thumb forceps Cotton applicator Tonsil forceps Laryngeal forceps Dressing forceps Needle holder Ear forceps Grasping forceps Pharyngeal forceps Biopsy forceps Towel forceps Gelfoam pressure forceps Swab forceps Turbinate forceps Septum forceps Punch forceps Adenoid forceps Nasal forceps TFL-FBX365R TFL-PLS Powered laser surgical instrument (TFL-AFSWL) TFL-FBX200BS TFL-FBX940R TFL-FBX365S TFL-CPLU TFL-SLS TFL-FBX150R TFL-FBX940S TFL-FBX550R TFL-FBX200S TFL-FBX550S TFL-FBX150BS TFL-FBX200R TFL-CSLU TFL-AFSW TFL-FBX150S Porous Hydroxylapatite Attic Defect McGee Off Center TORP Goldenberg PORP/TORP Black Oval TORP/PORP Shepard Grommet Tube Spoon-Bobbin Vent Tubes Dissector Tonsil dissector and retractor Woods Incus Stapes Goldenberg Incus Stapes Grote Incus Stapes Meyerhoff Incus Kartush Incus Stapes BIPOLAR COAGULATING FORCEPS SIF-Q180 Ti Bucket Handle Classic Stapes Pros. Tit. Shea Plat Cup Piston Lippy Mod Bucket Handle Titanium Richards Bucket Handle Titanium Richards BH Pros Flpl ALV-1 Double J Stent Iglesias Dissector Forceps PKS Dissectors Sheehy Weapon Sheehy Flap Knife ACMI Light Guide Adapters Killian Septum Speculum Buck Ear Currette Austin Tympanoplasty Richards Ritter-Halle Frontal Sinus Dilator Chest support Synergry Drill system Barnhill Adenoid Articulated arm and accessories Joseph Skin Hook Cottle Septum Speculum Bellucci Mic Scissors Double Spoon Biopsy Forceps RP Osteotome Delacruz measuring Russell-Davis Tongue Bld OTRP Trial Moriyama Univ. Cutt. Fcps Bojrab Dissector Black Oval Top Malony Mod PORP/TORP CYF-VHA CYF-5 CYF-VH MAJ-207 URO EZDilate BiCAP Hemorrhoid System MH-999E Plasma Cise Gyrus Urology Kit Gyrus Plasma V Plasma Cut Bantam Sm Chuck Handle Assy Endoscopic cord Adapter for Bovie Specialist Unit Vocom Vocal Cord Medial Shim Vocom Vocal Cord Mdlz Vacuum-powered body fluid suction apparatus Irrigation Bag Spike Assy Model 1120 MR-6LA MR-6A Steritray OPTHALMIC CAUTERY, FINE TIP, STERILE VASECTOMY CAUTERY,ELONGATED TIP HT GVAP LOOP ELECTRODE (5 PACK) (VRS ANGLED LOOP RESECTOSCOPE ELECTRODE) GVAP ELECTRODE (5 PACK) (VRS RESECTOSCOPE ELECTRODE) OEV321UH CW-5 Smart Malleous Pistons Smart 360 Pistons Smart Stapes Pistons Smart Dela Cruz Pistons Cutting Forceps PKS Cutting Forceps Everest Adapter cord Disposable Bipolar Cord Model 2420 VISTA Hook Scissors HALO Fergusson Suction Richards Sinuscope Hajek Sphenoid Suction Irrigation Sheath Frontal Ostium Forceps Fiber Optic Light Cable Autoclavable scope Grasping Forceps Irrigating Blade Diamond Burrs Diego Blades Viper Mastoid Burrs Mastoid Round Cutting Burrs Dermabrader Stapes Cutting Burrs Burr CV-170 Invisio OLYMPUS STERILIZATION TRAYS Olympus KeyMed Instrument Tray A5961, A5976, A05951A, A05961A,WA05970A, WA05971A , WA05972A, WA05973A, WA05974A, WA05990A, WA05994A, WA05995A Versapoint WA94020A HF cable "EndoTherapy", monopolar ST-CR Cyberwand FB-225U FB-215U FB-245U FB-210K FB-221K FB-242U FB-230K FB-210U FB-214U FB-235U FB-224U FB-222U FB-41ST-1 FB-211K FB-240K FB-234U FB-244U FB-50U-1 FB-240U FB-231K FB-241K FB-220K FB-230U FLEXIBLE BIOPSY FORCEP FB-212U FB-232U FB-220U FB-26N-1 PJF-160 PK J-Hook Falope Ring Band Applicator Kits Falope Ring Band Model 1010 UroPass II UroPass MAJ-1453 MAJ-1119 MAJ-422 MAJ-1193 Leakage Tester Adapter Light-guide Adapter Cleaning Accessories FG-V431P FG-V422PR FG-V432P FG-45U-1 FG-V421PR Renal Dilator Stent/GW Combo Ureteral Catheter OEV262H TEL-GT Tray ENDO-ST Tray MRA-GT Tray FGT-1 Tray EAWE-N Hartmann Tuning Fork EU-ME1 EU-ME3 GF-UCT180 MAJ-1720 Endoscopic instrument sterilization trays Various sterilization trays Diego instrument sterilization tray Tray MAJ-1215 ASV1012 Varipass Variable Access Sheath Trapeze Ribbon Loop Scissors E8218 DE Drill High Speed Drill Otoview scope Teleschi Suct ShockPulse POWERSEAL 2 Uropass Ureteral Access Sheaths Septum Needle Suction tupe BC-V600P-3010 CYB-2, CYB-3 Cord Gyrus PK Footswitch CW-4 Bovie generator HF-cables (reusable) Woodes Incudo Stapeidial joint Vokovic I-S Joint replacement plastipore Applebaum Incudo-stapedial PS-0021EJDA EBC05 EBC02 EBF02 EBF01 Everest Macro Bipolar Forceps Macro Bipolar Forceps Micro Bipolar Forceps Everest Micro Bipolar Forceps WOLF ADAPTER CORD Gauge pin G400 Workstation Telescope Instrument tray, for semi-rigid ureteroscope FTL-DEK-B BW-400V BW-403B MAJ-1339 BW-400B BW-411B BW-412T MAJ-1888 BW-400L Cleaning Accessory FTL-DEK-A Single Use Cleaning Brush Saw BLU Epistaxis Pack BLU Glide Nasal Pack BLU Nasal Pack PKS BiLL Protective Sheath InstaClear Light clip Light carrier Boucheron Ear Speculum Holmgren Speculum Hartmann Ear Speculum Politzer Ear Speculum Gruber Ear Speculum Speculum and accessories Autoclavable Scope Sinuscope OTV-SP1H-NA-12E OTV-S7H-1NA-12Q OTV-S7H-1NA-10E OTV-S7H-VA OTV-S7PROH-HD-12Q OTV-S7H-N OTV-S7H-1NA-12E LTF-S190-5 OTV-S7H-NA-12E OTV-S7H-1NA OTV-S7H-NA Pleatman Sac and accessories MAJ-1381 FG-52D FG-54D NA-201SX-4022 NA-201SX-4021 CH-S190-XZ-Q MAJ-2363 OTV-SI CV-1500 MAJ-2511 MAJ-2432 OTV-S200 OTV-S700 CLL-S700 MAJ-2512 CH-S700-XZ-EA CH-S190-08-LB Model 2220 Model 1200 21G EBUS Needle Gyrus G3 Generator Tilt-Top TORP Pros-Pls Sheehy TORP Shea Pls TORP Pros Shea Lg Hd Malleus Sheehy Modified TORP/PORP Pros E8213 GEN. SURGERY FORCEPS TB2-0535FC TB2-0520FC TB2-0525FC TB2-0545FC PBD-1030-1012 PBD-1030-0707 PBD-1030-1009 PBD-1030-0709 PBD-1030-1015 PBD-1030-0715 PBD-1030-0712 PBD-1030-1007 Syringe PK Lap Loop UCR Richards Pistons Piston Teflon/Wire Mangham Pistons Mass Eye and Ear Pistons Dela Cruz Pistons J PlasmaKnife Plasma J Hook Extender Cables Electrohydraulic Lithotripsy Probes Rasp Scoring instrument Raspatory Cartilage crusher Bone rongeur Cogent 1 Plasti-Pore Septal Button Silicone Septal Button VERSAPOINT GENERATOR BALL ELECTRODE (5 PACK) SPRING ELECTRODE (5 PACK) TWIZZLE ELECTRODE (5 PACK) FOOTSWITCH (SMALL) Foam head rest CF-H170I CF-H170L Double Pigtail MAJ-811 MAJ-843 Lowsley Electrode Blade Arthroscopes, CLV-S20 light source PKS Plasmaspatula Micro Bright Bivalve Splint Std Spetal Splint Std Neiman Sil RB Nasal Splint MAJ-686 PLASMA SECT UROLOGY Porous Hydroxlapatite granules Kartush Hydroxlapatite Disks PK Button Plasmasord UltraCatch X-Catch SecurCatch SurLock Flatwire SurLock Grasping Forceps Sur-Catch Baskets SurLock Graspers VC-10 DTAD Lubri-Flex Stents Disposable Electrosurgical Pencil Otomimix Otologic cement Nephro EZDilate Balloon Catheter AIL-220 Light Source ENF-VH ENF-V3 OTV-S500 Mallet CyberWand AUR-735 Biopsy Port Seals Accessory Kit NA-U401SX-4021 NA-U401SX-4022 Grote Canal Wall GW Lock POWERSEAL Hot Knives Vaportrode Loops Cold Knives 568618 Shepard Grommet Sheehy Collar Button Collar Button, Pacific Straight Vent Tube Reuter Bobbin, Pacific Armstrong Grommet IrriFlow EZDilate Silicone Single J TJF-Q170V PKS L-Hook Bilap L-Hook EIWE Endocapsule ChitoZolve Berger Bobbin Vent Tube Reut-Bob Vent Tubes Micron Bobbin Vent Tubes Fluoroplastic/Titanium Bobbin Micron Spoon Bobbin GY5-PCH TFL-AFC-NS, TFL-AFS150-NS, TFL-AFS200-NS, TFL-AFS365-NS, TFL-AFS550-NS, TFL-AFS940-NS Tip cleaner Holster 188 Duberstein applicator PK Cord PK generator SuperLoop SuperPulse generator SuperSect adapter Diego Trigger Console Diego Powered Dissector Diego Tube Set Diego Otology Tube Set Diego Lubri-Flex Telescope - autoclavable 20714 (HYSTEROSCOPE) GYNE-BR Invisio DUR-D BF-Q170 BF-1TQ170 FB-19SX-1 FB-221D FB-241D CLV-190 FB-231D Vocom Dolphin II Transducer Tubing Dornhoffer Ti PORP Flex Grasper Wehrs Incus Protheses Wehrs II Incus Stapes Neutral electrode cable Probe Needle for Nerve Stimulator Stimulator Probe Pod Sur-Lock Shea PORP Goldenberg Cap Shea Cap Shea TORP Ear forceps, inserter for ventilation tubes Inserter, for T-Tubes UltraTrack Hybrid Guidewire Amplatz E-Z Glider Bentson Quadra Coil Monopolar single-use HF cable PneumoLiner Powered Suction Pump Diego Elite Return Electrodes Frazier Suction Tube Baron Suction Tube Ferguson-Frazier Suction tube Verhoven Suction Tube Thunderbeat PK Diego Blades Diego Powered Dissectors Diego PK Console MAJ-528 Needle Sleeve Bending Tool Footswitch BICAP D-201-12704 D-201-10704 GIF-XP170N GIF-1TH190 GIF-H170 D-201-11804 D-201-15004 USG-410 TD-410 MAJ-2467 Ear loop Polyp snare Loop Ear curette House Wire Closure Forceps Seda Wire Closing Forceps McGee Wire Closing Forceps Otoview Cupped Forceps Guide Locking Pin Monopolar Cable Needle Nose Dissector Fulgurating Electrode Elite 2 System Reusable Active Cord Roller Electrode Stabilized Cutting Loops McCarthy Electrode Irrigation Tubing OSC5-STB OCS5-SR OCS5-STD OCS5-HA OCS5-TYS OCS5-TVAD1 OCSG-ZB OCS5-ETVM OSC5-BA OCS5-DCAD2 OCS5-LG Aspiration needle MAJ-860 SD-210U-15 MAJ-2051 MAJ-1177 MAJ-2088 MAJ-1917 MAJ-1834 MAJ-1828 MAJ-1832 MAJ-1827 Schuring Ossicle Columella Centered PORP/TORP Austin Modified TORP Spanner Strut Off-Centered PORP/TORP Dornhoffer Footplates universal Sheehy-Type Collar Button Richards T-Tubes Modified T-Tube Silicone Paparella-Type Vent Tubes Paparella 2000 GF-UC140P-AL5 MNT-120 H.264 MNA-110 ENC DVI MNA-110 ENC DP MNA-120 DEC DVI AUDIO MNA-240 Ouad Decoder MNA-120 ENC HDSDI AUDIO MNA-120 ENC DVI AUDIO MNA-110 ENC HDSDI MNA-120 ENC DP AUDIO Light-guide cable Diego Universal Adaptor Diego Starlink Handpiece WA91302W WA91307W WA91303W WA91301W PK-CF0533 WA91307C Viper Drill Diego Viper Turbo 7000 Rosette Packing Blu Ear Wick B-V231P-A RND SOPI OPI Micron II CTR TORP Monolithic All Titanium Micron II OCTR All Titanium TORP Micron II CTR PORP Monlithic All Titanium Adj. Micron Ti TORP Micron II OCTR PORP Monolithic All Titanium PK Spatula PK Needle MAJ-901 MAJ-902 HX-202UR HX-202LR HX-201LR-135L HX-201UR-135L HX-201LR-135 HX-201UR-135 Shepard Grommet Vent Tube Spoon-Bobbin Vent Tube Turner Drain Tube Pope Beveled Grommet Reut-Bob Vent Tube Applebaum Incus Replacement Grote Incus Prothesis Kartush Incus Strut Goldenberg Incus Prosth. SURGICAL CAUTERY, LOOP TIP STERILE SURGICAL CAUTERY, FINE TIP Celeris ViziShot 2 FLEX Bipolar Nasal cautery Mediastinoscope Occular Occluder Micro instrument wipe Shah Aural dressing Bovie Accessories PKS Needle PKS Omni MAJ-1862 Slimline E-Z Grip Guidewire Torque Device Head band Jahn Tube Hydroxlapatite Jahn Hydroxlvent Sof-Curl Multi-Flex Double J II Fixed Wire EZDilate 3-Stage Balloon Dilation Catheter BiCOAG Hemostasis Probe BiCOAG Causse Piston Fluoroplastic Piston Classic Stapes Prosthesis Arrigg II Piston Extend Blade Electrode VH-3200 Spare rod, vertical, for nasal snare Micro Forceps Macro Forceps MOLly Forceps SPIN Thoracic Navigation System VirtuoSaph Plus Endoscopic Vein Harvesting System 006902-902 Septal Needle Custom McGee Suction Tube Rains Frontal Sinus Stent PKS Seal Open Forceps Open Forceps OIP-1 Uro Guide Perc Antegrade ureteral stent Univ Ext Nasal Splint AF Nasal Splint Knife Hand peforator Needle Peforator Tonsil needle Williams Microclips Pick Knot pusher Hook Introducer Ear hook Tracheal hook Wide Line Nasal Pack 70140095 70890735 Slim Line Nasal Pack 70890732 70890738 70890730 70890737 70890751 70890739 70890743 70890742 70890753 70890740 70890752 70890734 70890728 70890733 70890754 70890731 70890756 70890729 70890750 70890741 70890755 70890757 Dual Lumen Catheter 2-3/4 Needle Electrode SlimLine Diego Spine Zimmer Diego Spine SB-0520FC SB-0535FC TD-SB400 SB-0545IC SB-0545FC TD-TB400 TB-0920OE TB-0535FCS TB-0520FCS MAJ-2412 SB-0520IC TB-0545FCS TB-0009OF SB-0535IC TB-0009OFX MAJ-1869 RC-2 Reusable Cable RC-20 Reusable Cable

    Establishment Types

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