FDA Registration Active 🇺🇸 United States

HALF PIN 6MM X 20MM

Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
Products
1
Proprietary Names
35
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

Regulatory Submissions

510(k) Number
K953397

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
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT

Proprietary Names

HALF PIN 6MM X 20MM DOUBLE PIN CLAMP HALF PIN 6MM X 85MM HALF PIN 6MM X 75MM HALF PIN 6MM X 65MM SS HALF PIN 6MM x 65MM STAINLESS STEEL HALF PIN 6MM X 35MM SS HALF PIN 6MM X 85MM SINGLE SWIVEL CLAMP SS HALF PIN 6MM X 20MM STAINLESS STEEL HALF PIN 6MM X 25MM Z-BAR ADD A SWIVEL TITANIUM HALF PIN 6MM X 45MM SS HALF PIN 6MM X 45MM Pelvic Ball Clamp UNIVERSAL RING ADAPTER HALF PIN 6MM X 30MM CENTERING SLEEVE 5MM DOUBLE SWIVEL CLAMP SS HALF PIN 6MM x 75MM COMP EX SHT HEX BAR-203MM UNIVERSAL SWIVEL CLAMP HEX BAR HEXFIX EX SHT 203MM AL SINGLE PIN CLAMP SS HALF PIN 6MM X 55MM DRIVE UNIT HALF PIN 6MM X 35MM SS HALF PIN 6MM X 30MM HALF PIN 6MM X 25MM RING ADAPTER TITANIUM HALF PIN 6MM X 55MM CENTERING SLEEVE 6MM HYBRID STRUT BAR CONNECTOR

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)