Sterigenics U.S., LLC

FDA Device Registration & Listing · Schaumburg, IL, US · Registration 1420032

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1420032
FEI Number
1420032
Entity Name
Sterigenics U.S., LLC
City/State/Country
Schaumburg, IL, US
Establishment Address
711 Cooper Ct, Schaumburg, IL 60173, US
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
Sotera Health LLC (Owner Number: 10029425)
Owner / Operator Contact Address
2015 Spring Road, Suite 650, Oak Brook, IL 60523, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Custom MedLabel Pack - Pack Name:San Pedro Universal Pack 1 Revision 0 Label or tag, sterile BTM217/50 BWT507/50 11166/20 17120/25 18880/20 RBL001/100 Key Surgical® Sterile Labels STL001/10 LTRED/50 11170/20 SVL002/100 LBL001/100 BNIML01/50 LTYELLOW/50 BTR230/50 PWL133/50 Labels, West Penn Package Name: Minor Plastic PBDS Pack Medication Labels, Parkview Hospital 5-Large w/ 10730 Revision 1 Labels, Reading Neuro Package Name: Med Labels - Neuro Custom MedLabel Pack - Pack Name:Upper Chesapeake Medical Center Revision 0 Custom MedLabel Pack - Pack Name:X-RAY LABELS Revision 0 Custom MedLabel Pack - Pack Name:SORS-SPC-105 Revision 0 Medication Labels,Package Name: Ortho/Total Joints Revision 2 Labels, Seattle Radiologists Package Name: Special Procedures Revision 1 Med Labels, Univ. of Mich. 1-Lg, 1-Xlg, 1-Sm, 1 Tally Sheet w/ 11735 & ruler Revision 2 Labels, UPMC St. Margarets Package Name: Eye medications Custom MedLabel Pack - Pack Name:Eye Labels 2 SM Custom MedLabel Pack - Pack Name:General Label Pack Custom MedLabel Pack - Pack Name:Ambulatory Surgery Pack Revision 0 Custom MedLabel Pack - Pack Name:Pain Management Labels Revision 5 Med Labels, Univ. of Mich 5-Lg & 1-Xlg, 1 Tally Sheet w/ 11730 Revision 3 Labels South Pointe Package Name: PAIN MEDICATIONS Custom MedLabel Pack - Pack Name:EP Lab Colored Blank Labels Revision 1 Custom MedLabel Pack - Pack Name:surgery1 Custom MedLabel Pack - Pack Name:WESTMEAD MODULE 3 Medication Labels, ICU Medical 2-small, 1-Xlarge sheet w/ 10730 DOUBLE POLY BAGGED Labels, Reading Plastics Package Name: Med- Labels- Plastics Custom MedLabel Pack - Pack Name:Surgery General Pack Revision 0 Custom MedLabel Pack - Pack Name:THRDenton- Dr. Chambers Custom MedLabel Pack - Pack Name:Lake Pointe Medical Center Revision 0 Custom MedLabel Pack - Pack Name:Cardiac Sterile Label Revision 0 Custom MedLabel Pack - Pack Name:Interventional Radiology Revision 2 Custom MedLabel Pack - Pack Name:Shellharbour Hospital Revision 0 Custom MedLabel Pack - Pack Name:OPTH/OCCU Medication Labels, Univ. of Michigan 1-Large, 4-Xlg, 1 Tally Sheet w/ 10730 & ruler Rev 1 Revision Custom MedLabel Pack - Pack Name:Local Med & ABX Labels Revision 0 Med Labels, Univ. of Mich 3-Lg & 1-Xlg, 1 Tally Sheet w/11730 Revision 3 Custom MedLabel Pack - Pack Name:IT CHEMO LABEL PACK_FINAL Revision 1 Custom MedLabel Pack - Pack Name:General Surgery Revision 1 Medication Labels, Package Name: Eye Pack Labels, West Penn Package Name: Nasal PBDS Pack Medication Labels, Package Name: Gyn Labels, Whitman Hospital 1 Small Sheets/Pack with 10730 Custom MedLabel Pack - Pack Name:Hoag Hospital - CVOR Labels Revision 0 Medication Labels, Parkview Huntington Hospital 4-small w/ 10730 Custom MedLabel Pack - Pack Name:General OR Labels Custom MedLabel Pack - Pack Name:BRCH Drug Labels Labels, Univ. of Mich 2-Large, 1-Small Revision 1 Custom MedLabel Pack - Pack Name:Cardiac Cath Labels Revision 7 Custom MedLabel Pack - Pack Name:Medication Labels Revision 2 Medication Labels, Package Name: General Surgery Labels w/SS LABELS, FAYETTE MED. 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Package Name: Genral Surgery Revision 1 Custom MedLabel Pack - Pack Name:NEURO 4 LG EZ w/ruler & marker Revision 1 Custom MedLabel Pack - Pack Name:sanfranva Revision 0 Custom MedLabel Pack - Pack Name:SORS-SPC-55 Custom MedLabel Pack - Pack Name:215 Surgery Custom MedLabel Pack - Pack Name:THRDenton- Dr. Mosier Medication Labels, Package Name: Pain Clinic Lables, Maine Medical Package Name: VIR sterile labels Revision 4 Custom MedLabel Pack - Pack Name:Surgery Labels Revision 4 Labels, West Penn Package Name: GYNE PACK Labels, West Penn Package Name: Head and Neck PBDS Pack Custom MedLabel Pack - Pack Name:Bx Drape Pack Labels Revision 1 Medication Labels, Package Name: General Pack Labels South Pointe Package Name: MEDICATION LABELS Custom MedLabel Pack - Pack Name:Angio Pack Revision 0 Med Labels, Univ. of Mich. 2-Lg, 1 Tally Sheet w/ 11730 Revision 2 Custom MedLabel Pack - Pack Name:ANGIO LABEL PACK Revision 0 Custom MedLabel Pack - Pack Name:Ophthalmology Medication Labels, Columbus Regional Hospital Revision 3 Custom MedLabel Pack - Pack Name:BBASC Revision 1 Labels, Emory Clinic Retina 2 sm per pack w/10730 Custom MedLabel Pack - Pack Name:Munroe Regional Medication Labels Revision 2 Custom MedLabel Pack - Pack Name:NSCCAHS Sterile Labels Revision 0 Labels, St. Clares Hosp. 1-Small, 2-Xlg w/ 11730 Custom MedLabel Pack - Pack Name:GENERAL/VASC/ENT/UROLOGY Custom MedLabel Pack - Pack Name:Dr. Leon Medication Label, Package Name: General Pack Revision 1 Custom MedLabel Pack - Pack Name:Sequoia Med Labels Custom MedLabel Pack - Pack Name:cath med labels Revision 4 Labels, Akron Surgery Ctr Package Name: Surgery Revision 2 Custom MedLabel Pack - Pack Name:Doylestown Surgery Center-Eye Labels Revision 1 Labels, West Penn Package Name: Minor General Pack Medication Labels, Package Name: Spinal Pack Custom MedLabel Pack - Pack Name:OTO EAR Revision 1 Custom MedLabel Pack - Pack Name:General Surgery Labels Medication Labels, Package Name: ENT Pack Medication Labels, Package Name: Hannibal-Cardiac-Sterile Med Labels, Univ. of Mich. 4-Lg, 1 Tally Sheet w/ 11730 Revision 4 Medication Labels, Univ. of Michigan 1-Lg,6-Xlg,1 Tally Sheet w/ 10730 & ruler Revision 2 Custom MedLabel Pack - Pack Name:Eye Labels Revision 1 Custom Medlabel Pack - Pack Name:EAA Medication Labels Revision 5 Custom MedLabel Pack - Pack Name:Torrance Blank Labels Revision 0 Labels, Leo McCafferty 4-small, 3 -xlg w/ ruler& marker Revision 3 Labels, Big Fork Package Name: Surgery Custom MedLabel Pack - Pack Name:THRDenton- Dr. Cobos Revision 1 Custom MedLabel Pack - Pack Name: Medica Imaging Label Pack Revision 0 Custom Med Label Pack - Pack Name:Sterile Labels Revision 0 Custom MedLabel Pack - Pack Name:Mercy Hospital Lebanon Labels, Reading Oculoplastic Med Labels- Oculoplastic Custom MedLabel Pack - Pack Name:Misc. 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IMA/ENT 6" EXT NEEDLE ELECTRODE DISP 6 " EXT 3/4" BLADE ELEC 24 DISP IMA/ENT 6" EXT 3/4" BLADE 24 EA ISI DA VINCI S 8MM LONG OBTURATOR DISP. IMA/ENT 3/4" BLADE ELECTRODE DISP. IMA/ENT 3/4" NEEDLE ELECTRODE Reactor(TM) Trocar and Sleeve VasoStat® Hemostasis Device Zinnanti Smoke Evacuation Tubing Kit NST336/20 4905/25 19655/20 NST010/20 19611/25 19144/25 17763/50 19695/25 19689/20 19675/20 19662/20 19620/20 19685/20 MFT006/20 19669/05 19670/50 19639/50 17601/50 17602S/20 19632D/25 19726/20 19668/20 19630/25 19081/24 17756/50 17743/50 19615/25 NST041/20 19674/20 19683S/20 19633/20 13696/10 19621/20 19721/20 19728/20 19684/25 19616/25 19711CS/300 19619/25 19610/25 19638/20 17764/50 19729/100 NST043/20 19706/50 19682/20 19719/20 19711/300 NST033/20 19724/20 19671/20 19695/20 19618/20 19641/20 19677/20 19698/50 NST138/50 NST030/20 19613/25 19725/20 19634/25 NST040/20 19648/20 19653/20 NST045/20 19649/20 19625/50 19642/20 19692/50 SST001/50 19723/50 17766/50 19652/20 19730/20 19624/50 NST037/20 19667/20 19605C/20 19684/50 17619/25 19678/20 NST038/25 NST031/25 19690/25 19651/25 19632/20 19658/25 19657/20 19673/20 19727/20 19643/20 19686/50 MFT004/20 19718/20 17751/25 17641/50 19709/20 19733/50 NST034/25 19732/20 NST035/20 19722/20 19602S/20 19680/25 19672/50 19683W/20 19659/20 19082/24 19640/20 19629/20 17769/50 19705/20 NST038/20 19620D/20 19713/50 19637/20 NST011/10 19636/20 NST042/25 19635/20 19720/20 19736/25 19663/20 19676/20 NST039/20 19627/20 19660/25 19634/20 19716/20 19656/25 19623/20 17768/50 19646/25 19647/25 19665/20 19625/25 19645/25 17611/50 19644/20 19691/20 19717/20 19631/20 19679/20 19707/10 NST032/25 17602/50 19712/20 NST036/20 17332W/05 19664/25 19715/20 17751/50 19050/25 17762/50 NST136/25 Molded Connector Tube: 888284505 Connect Tube: 8888284745 Spike Entry Port S/A (HP-IRR) Connect Tube: 8888284703 Molded Connector Tube: 8888301630 Molded Connector Tube: 8888301645 Molded Connector Tube: 8888301622 Molded Connector Tube: 8888301713 Connector: 155659 Connect Tube: 8888284638 Connect Tube: 8888284547 Connect Tube: 8888284620 Molded Connector Tube: 8888301523 Molded Connector Tube: 8888301705 Connect Tube: 8888284604 Molded Connector Tube: 8888301739 Spike Entry Port S/A (HP-NIR) - 128402000 Molded Connector Tube: 8888301606 Molded Connector Tube: 8888301507 Molded Connector Tube: 8888301531 Connect Tube: 8888284539 Connect Tube: 8888284612 Connector: 155658 Connect Tube: 8888271007 Molded Connector Tube: 8888301509 Molded Connector Tube: 8888301515 Connect Tube: 8888284521 Connect Tube: 8888284711 Molded Connector Tube: 8888301549 Molded Connector Tube: 8888301721 Connect Tube: 8888284554 Molded Connector Tube: 8888301609 Spike Entry Port S/A (HP-IRR) - 201739000 Spike Entry Port S/A (HP-NIR) Connect Tube: 8888284737 Molded Connector Tube: 8888301614 Connect Tube: 8888284513 5-in-1 Connector ConchaPak CONCHAPAK SW 1650 ML W/MIN COMP COLUMN Weck TAUT TAUT CHOLANG CATH10/BX 4.5 FR TIP X 18" TAUT CHOLANG CATH10/BX 4.5FRx30" no MST TAUT CHOLANG CATH10/BX 6.5 FR TIP X 18" TAUT INTRADUCERS 10/BX10 FR X 8" TAUT INTRADUCERS 10/BX 8RF X 3.5" TAUT CHOLANG CATH10/BX 4.5 FR TIP X 30" TAUT CHOLANG CATH10/BX 6.5 FR X 18" TAUT CHOLANG CATH10/BOX 4.5 FRX 18" TAUT CHOLANG CATH10/BX 7.5 FR TIP X 18" TAUT INTRADUCERS 10/BX7.5 FR X 3.5" TAUT CHOLANG CATH10/BX 5.5 FR TIP X 18" TAUT CHOLANG CATH10/BX 5.5 FR X 18" TAUT INTRADUCERS 10/BX4.5 FR X 3" PI-104; TAUT INTRACUDERS 10/bx 8FR X 3.5 PI-128; TAUT INTRADUCERS 10/BX 10FR x 8 TAUT ACCESS PORT W / STABILITY 3/5 X 70MM Amerigel Meijer Saline Wound Wash Medzone Curad Saline Wound Wash Steri-Wash K053321 Light, Surgical, Accessories PILLING Medichoice Rigid Handle Rigid Light Handle 60881 1 ea 64/case Semi-Rigid Light Cover 2/pack Light Handle Cover 2/pkg Light Handle Cover 1/pkg Light Handle Cover 3/pkg Semi-Rigid Light Handle Cover Medichoice Light Handle Cover (80 Packs of 2). Light Handle: 60512 Light Guard Rigid 1/pkg Sterile Medichoice Light Handle Cover Light Handle Cover 60513 3/pk 64 pk/case Sterile Light Guard Rigid 2/pkg Sterile - (40 packs of 2) Medichoice Rigid Handle (40 Packs of 2). Light Handle Rigid: 60882 Medichoice Light Handle Cvr Light Handle Cover 60511 1/pk 160/case Sterile Weck Vista TAUT ACCESS PORT W / STABILITY 15 X 110MM TAUT ADAPt 15MMX 110MM BARIATRIC PORT TAUT ADAPt PORTS 10/12MM X 125MM LONG TAUT ADAPT PORTS 5/10MM UNIVERSAL TAUT ADAPt 3/5MMXO 70MM PED PORT UNIVERSAL BALLOON OPEN ACCESS PORT LONG UNIVERSAL BALLOON OPEN ACCESS PORT - 10X UNIVERSAL BALLOON OPEN ACCESS PORT SHORT TAUT ADAPt 10MM BALLOON PORT UNIVERSAL BALLOON OPEN ACCESS PORT - 12X 412944L; WECKVISTA ACCESS BALLOON PORT 12MMX100MM EXP-Pak¿ Hudson RCI Aquapak Nebulizer Comfort Flo Humidification System Confort Flo Humidification System with Weck Weck Vista TAUT TAUT SYSTEM ONE TRIFECTA BALLOON 5FRX75 Weck TAUT CAP DRAINS 20/BX LATEX FREE 18"X3/4 TAUT CAP DRAINS 20/BX LATEX FREE 12"X3/4 TAUT CAP DRAINS 20/BX LATEX FREE 18"X1/4 TAUT CAP DRAINS 20/BX LATEX FREE 12"X1" TAUT CAP DRAINS 20/BX LATEX FREE 12"X12" TAUT CAP DRAINS 20/BX LATEX FREE 18"X1/2 TAUT CAP DRAINS 20/BX LATEX FREE 18"X1" TAUT CAP DRAINS 20/BX LATEX FREE 18"X3/8 TAUT CAP DRAINS 20/BX LATEX FREE 12"X3/8 TAUT CAP DRAINS 20/BX LATEX FREE 12"X1/4 CONCHA COLUMN SHELFPAKADULT PAR CONCHAPAK SW 1650 ML W/COLUMN CONCHA COLUMNSTD RIGHT ANGLE INTL K063587 Gastroenterology/ Urology Anti-Fog w/ Pad; in Tray Anti-Fog w/ Pad; Private Labeled for ROI; ROI #236167 Anti-Fog w/ Pad Weck Vista TAUT ADAPt REDUCERCAP TAUT ADAPT 5/10MM UNIVERSAL DISPOSABLE C

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-10-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-06-09
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-06-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-12-11
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-12-11
LYV Label Or Tag, Sterile General, Plastic Surgery Class 1 878.4800 2012-11-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-12-11
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2013-06-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-06-06
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2013-06-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-03-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-06-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2019-10-18
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2022-01-18
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2012-11-01
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2013-06-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-06-06
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-04-12
JEY Plate, Bone Dental Class 2 872.4760 2013-06-06
FRO Dressing, Wound, Drug Unknown Class U N/A 2012-11-28
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2019-10-18
MSB System And Accessories, Isolated Heart, Transport And Preservation Gastroenterology, Urology Class 2 876.5880 2019-10-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-06-09
FTA Light, Surgical, Accessories General, Plastic Surgery Class 2 878.4580 2012-11-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-06-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-06-09
QJY Infusion Pump, Drug Specific, Pharmacy-Filled General Hospital Class 2 880.5725 2025-05-20
KJF System, Suspension, Cell Culture Hematology Class 1 864.2240 2012-11-01
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2017-08-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-06-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-03-15
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2013-06-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-06-10
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-10-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-12-11
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2026-05-13
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-06-06
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2013-06-06
OCT Anti Fog Solution And Accessories, Endoscopy Gastroenterology, Urology Class 2 876.1500 2012-11-14
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-06-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-12-11

Official Correspondent

Karen Whaley-Krumins

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sotera Health LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3005914490 UNIDADE DE ESTERILIZACAO COTIA LTDA. Cotia Sao Paulo, BR
9680579 Sterigenics Radiation Technologies Canada, Inc PORT COQUITLAM British Columbia, CA
3008132411 Sterigenics Shanghai E Beam Ltd. Shanghai, CN
9616517 Sterigenics S. de R.L. de C.V. Tepeji del Rio de Ocampos Hidalgo, MX
3008328679 Sterigenics S. de R.L. de C.V. Cuautitlan Izcalli Mexico, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1420032. Last updated year: 2026. Please use registration number 1420032 when referencing this establishment in official correspondence.
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