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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-11-01 |
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)