FDA Registration Active 🇺🇸 United States

Suture Hook

Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
Products
1
Proprietary Names
366
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Sterigenics US LLC
Registration Number
3002907620
FEI Number
3002907620
Status
Active
Expiry Year
2025
Initial Importer
No
Address
1700 College Blvd.
City
West Memphis
State
AR
ZIP
72301
Country
US

Owner / Operator

Firm Name
Sotera Health LLC
Operator Number
10029425
Address
2015 Spring Road, Suite 650
City
Oak Brook
State
IL
Postal Code
60523
Country
US
Correspondent
Karen Whaley-Krumins

Products

Device Name Product Code
Orthopedic Manual Surgical Instrument LXH

Proprietary Names

Suture Hook Arthroscopic graft delivery kit Arthroscopic Disposables Kit Orthopedic Manual Surgical Instrument 4.7mm Knotless anchor drill kit Expectrum MVP Carpal Tunnel Cutting Blade Access Tool, Diamond Stylet Suture Retriever Trinica ORTHOPEDIC MANUAL SURGICAL INSTRUMENT NeoSpan implant screw kit Access Tool, Blunt Cannulated Stylet Access Tool, Access Cannula CONCEPT Shuttle Relay Graft Guard Access Tool, Spacer Bullseye Parasmillie General Surgical Instrument Super Shuttle Concept Suture Passer, needle Ankle Distractor Strap ICMC Sizing Trial Ceterix Disposable Suture Passer Trinica - Anterior Lumbar Plate Sys XIA PRECISION (48237105, 48237110, 48237115, 48237135) FEM/REC DR 4.8X 311MM THIN OSTEO BLADE 8 X 5 2.5MM/3MM COUNTERSINK W/QC LARGE - PARTIAL HALF PIN - INSTRU MODULE 2MM GUIDE ROD X 900MM SMOOTH 4.5 DRILL BIT {} 180/165MM NQC MINI - UNI EXT FIXATOR SYSTEM REVERSE VERBRUGGE {} 190MM 4.5MM TGR TAP Q/QC 3.2MM SHORT GRAD BRAD PT DRILL 3.5MM DRILL W QC GD RD F/RMR BL TP 2X700 2.5 DRILL BIT {} QC 110/85 GOLD 3.2 DRILL BIT {} QC 195/170 2MM DRILL W/QC DRILL LG 5MM HALF PIN STERILE GUIDE PIN TRO PT 1.3 X140 PERI-LOC 4.5MM PF PIN 80MM SHORT 1.25 WIRE CAP DIAMOND POINT PIN {} 1.9MM HOHMANN RETRCT L ONG {} 15MM GNS SAWBLADE- 3M ATTACH 2.7MM PF PIN 40MM TRIGEN DISPOSABLE EXTRACTOR ROUTER {} QUICK COUPLING GUIDE PIN 3.2MM X 230MM 2.5 DRILL BIT {} QC 180/155 GOLD JOYSTICK THREADED PIN {} SMALL TARGETER 2.7MM DRILL BIT W/QC 2.7MM TAP W/QC TROCAR PIN {} 2.7MM X 216MM PIN DRIVER THIN OSTEO BLADE 8 X 3 3.2MM TIP THREADED GUIDE PIN ASIAN IMHS 3.2 GUIDE PIN CANN STDRL F/8 CANN SCR PERI-LOC 2.7MM DRILL GUIDE PF PIN 25MM GUIDE PIN BAY PT 1.3X140 SMALL FRAG COUNTERSINK GD RD F/RMR-SPADE 3.2X900 PERIOSTEAL ELEVATOR 6MM STR RT DRILL 3.5MM 2MM CANN DRILL BIT W/QC PERI-LOC SCREW HOLE FILLER JET-X 4.8MM STEP DRILL -6MM HP STDRL 8 RECON PROX SCR PERIOSTEAL ELEVATOR GEN TROCAR PIN 1/8 SCREW DRIVER RELEASE HANDLE STERILE 6.4MM DRILL TROCAR PIN {} 4MM X 240MM GENII SAW BLADE LONGER 2MM DRILL BIT W/ QC - 157MM BOHRER 38 MM FUR COLE RONTGENDURCHL.WINK 6.5MM CANCELLOUS TAP QC K WIRE TRO PT 1.9X230MM PERIOSTEAL ELEVATOR-6MM CURVED CANN STDRL F/6.4 CANN SCR 2MM DRILL 191MM 4MM LONG AO PILOT DRILL 4.5MM CANN DRILL {} BIT W/QC INT TWIST DRILL - 2.7MM 3.2 X 230MM THREADED TIP GUIDE PIN GD RD F/RMR CVD 3.2X900MM THREADED TIP GUIDE PIN 4.5 DRILL BIT {} QC 196/170 3F 4.5MM SHORT DRILL BIT W/QC LARGE - BAR MODULE TROCAR PIN 3.5MM X 330MM REPLACEMENT RUBBER KIT 3.2 DRILL BIT {} QC 230/205 3F SAW BLADE ATTACHMENT AMSCO-HALL 2MM WIRE CAP BRAD-TIP DRILL BIT 4 X 180MM 3.5MM GRAD BRAD PT DRILL 2.5MM/3MM CLEANING BRUSH 3.2 DRILL BIT {} QC 145/120 PERI-LOC CABLE SADDLE SHORT GD ROD F/NAIL STR 3X900 3.5MM DRILL BIT W/QC SB RAD OSTEO BLADE SZ 10 .2.5 DRILL BIT {} QC 230/205 3F RAD OSTEO BLADE SZ 14 JET-X {} DRILL SLEEVE-ST/XSHT HP DRILL LG 6MM HALF PIN STERILE MCGLAMRY ELEVATOR CODA CTR 2.7MM DRILL 191MM BOHRER 43 MM FUR COLE RONTGENDURCHL.WINK 6.5/8MM CANN COUNTERSINK REVERSE VERBRUGGE 190MM 2 DRILL BIT {} QC 100/75 REF ACET CUP POS/IMP TIP THIN OSTEO BLADE 10 X 5 2MM PF PIN 14MM 1.1MM WIRE CAP 2.7MM SHORT DRILL {} BIT W/QC GUIDE PIN TIP THRD 3.2 X 300MM PERI-LOC VLP 2.7MM X 25MM PF PIN GD RD F/RMR STR 3.2X900MM LARGE FRAG COUNTERSINK SPECTRUM II SUTURE HOOK, DISPOSABLE, 60 DEGREE LEFT, QTY 5 Q-Fix Disposable Kits 1.1 DRILL BIT {} 45MM NQC SHORT 3.5MM BRAD PT DRILL THIN OSTEO BLADE 12 X 3 1.1 DRILL BIT {} QC 60/35 THIN OSTEO BLADE 20 X 3 JOYSTICK THREADED PIN {} LARGE FREER ELEVATOR 3.2MM X 305MM GUIDE PIN 2 DRILL BIT {} 110MM NQC THIN OSTEO BLD ROUND END 12MM 3.2 MM GUIDE PIN 3.5MM DRILL {} BIT W/QC DRILL 10 CM LONG 3.5MM NEUTRAL LCK HOLE INSRT 3.2 TIP THREADED GUIDE WIRE EZ Pass Key Surgical® K-Wire and Pin Covers Spineology Powered Bent Tissue Extractor Brush Catalog# 315-0025 SHUTTLE-RELAY SUTURE PASSING SYSTEM, QTY 10 PERI-LOC 2.7MM DRILL GUIDE PF PIN 14MM TROCAR PIN {} 3.5MM X 240MM SPECTRUM II SUTURE HOOK, DISPOSABLE, 45 DEGREE LEFT, QTY 5 BIOSCREW HYPERFLEX GUIDEWIRE, NITINOL, 14 IN, STERILE, 1.1 X 356MM (45 X 14IN) PERI-LOC 3.5 PF PIN 18MM SHORT 4MM SHORT AO PILOT DRILL 2NM TORQUE LIMITER 2.7MM SHORT DRL BIT W/QC SB 2.7MM SHORT DRILL BIT W/QC 2.7 DRILL BIT {} QC 125/100 4MM LONG PILOT DRILL SEMIEXTENDED TAPERED ENTRY TUBE 1.5 DRILL BIT {} 95MM NQC PERI-LOC TGR 4.5MM PF PIN 80MM 3.2MM X 358MM TGR DRILL BIT 3.5MM SHORT DRILL {} BIT W/QC CANN DRILL F/HA PINS 3.8MM 3.5MM PF PIN 18MM 3.5MM TGR TAP Q/QC GENESIS PIN AND DRILL SET 2MM DRILL 130MM 2.7MM PF PIN 18MM PERI-LOC CABLE SADDLE TALL 4.5 DRILL BIT {} QC 145/120 3.2MM TIP THREADED GUIDE WIRE GD ROD F/NAIL STR 4X900 3.2 X 230MM DRILL TIP GUIDE PIN 4.5 DRILL BIT {} QC 195/170 RT TIB DRILL 4MMX305MM 4MM CANNULATED TAP W/ QC 3MMX900MM BALL TIP GUIDE ROD HOHMANN RTR B {} 8MM WIDTH 2.7 DRILL BIT {} QC 100/75 3.5MM X 90MM DRILL STDRL ALL 6.4 REC PROX SC TWIST DRILL (2.7MM X216) 3.2MM X 358MM DRILL TIP GUIDE PIN 2.7MM DRILL {} BIT W/QC PILOT DRILL 3.2MM X 76MM 3.2 DRILL BIT {} 130/115MM NQC 3.2MM X 300MM DRILL BIT W/QC PERI-LOC SM FRAG INST & IMPLANT SET 2MM PF PIN {} AO CONNECT 18MM SPIR GIGLI SAW BLADE 20 3.2 X 300 DRILL TIP GUIDE PIN REFL ACET SCREW DRILL 35MM LENGTH THIN OSTEO BLADE 10 X 3 TARGETER 3.5MM DRILL BIT W/QC 2 DRILL BIT {} QC 125/100 GNS AH/STRY RMR/JAC QUIK CONN TIPTHRD GDE PIN 3.2MM 385MM DRILL SH 6MM HALF PIN STERILE JET-X MINI DISTAL RADIUS HALF PIN DRIVER 3.5MM SHORT DRILL BIT W/QC Manos REF TPR HOLE CVR INSERTER IMHS 3.5MM TWIST DRILL DRILL BIT (SHORT) 3.5MM 2MM GRAD BALL TIP GD ROD 2.7MM STEPDRILL - SHORT 3.5MM PF PIN 40MM CANN. DRILL F/HA PINS {} 4.8MM 4.5MM TAP QC 2.7MM CANNULATED DRILL BIT - 155MM 4.5MM X 90MM DRILL PERI-LOC VLP 2.7MM X 40MM PF PIN 3.5 DRILL BIT QC 110/85 RAD OSTEO BLADE SZ 16 KYPHON® Osteo Introducer® System HANDLE {} MINI BULB S/D {} QC GNS STRYKER DRILL QUIK CONN 2.7MM DRILL 130MM 3.5MM DRILL 191MM TARGETER 4.5MM DRILL BIT W/QC Kyphon Osteo Introducer Devices ROTATOR CUFF REPAIR INSTRUMENTS SUTURE RETREIVER, SMALL, 6 EA Y-Knot RC Disposable Broaching Punch, 2.8mm GRAFT PASSER 10 EA PERI-LOC TGR 3.5MM PF PIN 18MM 3.2MM TROCAR REVERSE VERBRUGGE {} 280MM Esser Pelvic Guide RAD DRILL GUIDE REVISION NAIL 2MM PF PIN 25MM PERI-LOC 4.5 PF PIN 80MM SHORT COMBINATION TOOL 3.2MM LONG GRAD BRAD PT DRILL TGR LG FRAG 4.5MM CAN DRL W/QC 3.5 DRILL BIT {} 95/80MM NQC N8TIVE ACL Disposables Kit 3.2MM X 300MM GUIDE PIN SPECTRUM II SUTURE HOOK, DISPOSABLE, LARGE CRESCENT, QTY 5 EXTENDED LENGTH SPECTRUM MVP SUTURE PASSER, DISPOSABLE, CRESCENT, MEDIUM, QTY 3 3.5MM SHORT DRL BIT W/QC SB 2MMX900MM BALL TIP GDE ROD EXTENDED LENGTH SPECTRUM MVP SUTURE PASSER, DISPOSABLE, 45 DEGREE LEFT, QTY 3 3.5MM DRILL 130MM SAW BLADE ATTACHMENT STRYKER ROTATOR CUFF REPAIR INSTRUMENTS SUTURE RETRIEVER, LARGE, 6 EA 3.2MM X 300MM DRILL TIP GUIDE PIN PARASMILLIE BLADE 11MM, QTY 5 3.2MM X 343MM BRAD POINT TIP GUIDE PIN COUNTERSINK DRILL EX SH 5MM HALF PIN STERILE TIP THR GDE PIN 2.4X305 1.6MM WIRE CAP 1.5 DRILL BIT {} QC 110/85 THIN OSTEO BLD ROUND END 20MM EXTENDED LENGTH SPECTRUM MVP SUTURE PASSER, DISPOSABLE, 45 DEGREE RIGHT, QTY 3 CONCEPT SUTURE PASSER NEEDLE, QTY 5 KYPHON® EXPRESS™ Osteo Introducer® System DRILL, 2.4MM BIOSCREW GUIDEWIRE, SST, 14 IN, STERILE, 1.1 X 356MM (45 X 14IN) PERI-LOC SM FRAG INST & IMPLANT SET LID REVERSE VERBRUGGE {} 240MM 5MM SHORT PROTECTOR 3MM CANNULATED DRILL BIT W/ QC 1.8MM CANNULATED DRILL BIT W/QC RAD OSTEO BLADE SZ 12 600MM BALL TIP GUIDE ROD GUIDE PIN TIP THRD 1.9 X 300MM PELVIS PIN DRILL SH 5MM HALF PIN STERILE 2.7MM DRILL W/QC SPIR GIGLI SAW BLADE 12 JET-X TP/ DS FOR 6MM HALF PINS 2.7 DRILL BIT {} 110/95MM NQC KYPHON® EXPRESS™ Advanced Osteo Introducer® Device TGR 3.5MM DRILL TIP PF PIN 18MM JETX DS/TROC F/5 & 6MM SHT HP DRILL BIT 1.5 QC 85/60 PERI-LOC 3.5MM PF PIN 18MM SHORT 2MM SHRT DRLL BIT W/QC SEMIEXTENDED ENTRY TUBE 7MM COMPRESSION SCREW DRILL Accessory Portal Kit Kyphon V Vertebroplasty Kits with CDS KYPHON® Osteo Introducer™ System 4.5MM DRILL BIT W/QC 3.2 DRILL BIT {} 180/165MM NQC PILOT DRILL {} 3.2MM X 127MM 4MM SHORT DRILL PED TWIST DRILL - 2MM PERI-LOC VLP 2.7MM X 14MM PF PIN ACETABULAR PIN MANOS Carpal Tunnel Release System BIOSCREW HYPERFLEX GUIDEWIRE, NITINOL, 18.5 IN , STERILE, 1.1 X 470MM (45 X 18.5IN) HIGH STRENGTH GUIDE PIN, 9 IN, STERILE, 2.4 X 229MM (93 X 9IN) SPECTRUM II SUTURE HOOK, DISPOSABLE, STRAIGHT, QTY 5 3.2MM TIP THREADED GD PIN 2.4MM TAP W/AO QC 4.5MM X 90MM CANNULATED DRILL GUD PIN TIP THRD 3.2 X 358MMCC REFL ACET SCREW DRILL 25MM 3.2MM X 300MM THR GUIDE PIN 3.5MM TAP QC PERI-LOC 4.5 TGR PF PIN 80MM GNS TROCAR PIN 1/8 in. X {} 5in 4.5 DRILL BIT {} 130/115MM NQC 3.5 DRILL BIT {} QC 195/170 2MM TAP W/AO QC IMHS 3.2MM X353MM GDE PIN Spineology Straight Fill Tube Catalog# 300-1008 SPECTRUM II, SUTURE HOOK, DISPOSABLE, 60 DEGREE RIGHT, QTY 5 SPECTRUM MVP SUTURE PASSER, DISPOSABLE, 45 DEGREE RIGHT, QTY 3 HYPERFLEX GUIDEWIRE, NITINOL, 18.5 IN, STERILE, 1.6 X 470MM (62 X 18.5IN) SPECTRUM MVP SUTURE PASSER, DISPOSABLE, CRESCENT, MEDIUM, QTY 3 ToggleLoc System SPECTRUM II SUTURE HOOK, DISPOSABLE, MEDIUM CRESCENT, QTY 5 1.3MM CANN COUNTERSINK W/QC 2.5 DRILL BIT {} 95MM GOLD NQC TRAY {} BLADE PLATE INSTS COUNTERSINK {} 1.5/2MM GEN SPECIAL TROCAR PIN 1/8"X3" 3.5 DRILL BIT {} 180/165MM NQC PARASMILLIE BLADE 9MM, QTY 5 ROTATOR CUFF REPAIR INSTRUMENTS SUTURE RETRIEVER, MEDIUM, 6 EA SPECTRUM II SUTURE HOOK, DISPOSABLE, 45 DEGREE RIGHT, QTY 5 Kyphon V Vertebroplasty Devices DRILL, CANNULATED, 10MM HYPERFLEX GUIDEWIRE, NITINOL, 14 IN, STERILE, 1.6 X 356MM (62 X 14IN) Spineology Powered Tissue Extractor Brush Catalog# 315-0023 PARASMILLIE BLADE 10MM, QTY 5 BULLSEYE FEMORAL GUIDE END PLUG, QTY 5 Spineology Facet Drill Catalog# 315-0015 SUPER SHUTTLE SUTURE PASSING SYSTEM, QTY 8 SPECTRUM MVP SUTURE PASSER, DISPOSABLE, 45 DEGREE LEFT, QTY 3 SPECTRUM II SUTURE HOOK, DISPOSABLE, SMALL CRESCENT, QTY 5 ACL Disposable Kit Kyphon Latitude and Express Curettes Spineology Manual Bent Tissue Extractor Brush Catalog# 315-0024 Spineology Manual Tissue Extractor Brush Catalog# 315-0022 OsteoCool Bone Access Kits AMK FIXATION PINS Spineology Diverted Fill Tube Catalog# 300-0009 HYPERFLEX GUIDEWIRE, NITINOL, 9 IN, STERILE, 1.6 X 229MM (62 X 9IN) 6MM X 50MM DISPOSABLE CANNULA W/ OBTURATOR, THREADED, 6 EA KyphonLatitude and Express Curettes Kyphon Osteo Introducers and OsteoCool Bone Access Devices RECLAIM ASSEMBLY TENSILE BAR 0206-711-000;0206-716-000;0206-716-000S2 4mm AlloMate Instrument System 2.5mm AlloMate Instrument System 3mm AlloMate Instrument System 3.5mm AlloMate Instrument System 2mm AlloMate Instrument System KYPHON® LATITUDE® II and Express Curettes MISHA™ Knee System Fixation Kit Orthoapedic Manual Surgical Instrument AlloAid® cartilage mixing kit Disposable Cannula Access Tool, Fortibrae Access Cannula Access Tool, Trocar Stylet 6198-001-514 Carpal Tunnel Blade 5 Pack Hip Cup Insertion Tool Invictus

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)