FDA Registration Active 🇺🇸 United States

7 X 30 MM SOFTSILK SCREW 1.5 STERILE

Reg #: 1643264 · FEI: 1643264 · Expires 2025
Products
1
Proprietary Names
28
Establishment Types
1
Classifications
1

Registration Details

Registration Name
SMITH & NEPHEW INC.
Registration Number
1643264
FEI Number
1643264
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
ENDOSCOPY, 76 S. MERIDIAN AVE.
City
OKLAHOMA CITY
State
OK
ZIP
73107
Country
US

Regulatory Submissions

510(k) Number
K921481

Owner / Operator

Firm Name
Smith & Nephew, Inc.
Operator Number
1020279
Address
2875 Railroad Street
City
Pittsburgh
State
PA
Postal Code
15222
Country
US
Correspondent
Lisa Ewing

Products

Device Name Product Code
Screw, Fixation, Bone HWC

Proprietary Names

7 X 30 MM SOFTSILK SCREW 1.5 STERILE CANNU-FLEX 9 MM X 20 MM 1 SCREW, STERILE DRIVER SILK SCREW 1.5MM MTO, SOFTSILK SCREW Cannu-Flex Screw 9 X 20 MM SOFTSILK SCREW 1.5 STERILE 8 X 25 MM SOFTSILK SCREW 1.5 STERILE CANNU-FLEX DRIVER SILK SCREW 7MM CANNULATED CANNU-FLEX 6 MM X 20 MM 1 SCREW, STERILE 8 X 20 MM SOFTSILK SCREW 1.5 STERILE CANNU-FLEX 6 MM X 30 MM 1 SCREW, STERILE MTO SCREW SOFTSILK 1.5 10 X 20 STERILE 7 X 20 MM SOFTSILK SCREW 1.5 STERILE 8 X 30 MM SOFTSILK SCREW 1.5 STERILE 9 X 30 MM SOFTSILK SCREW 1.5 STERILE CANNU-FLEX 9 MM X 30 MM 1 SCREW, STERILE CANNU-FLEX 9 MM X 25 MM 1 SCREW, STERILE Screw, SoftSilk, CANNU-FLEX 8 MM X 20 MM 1 SCREW, STERILE DRIVER,CANNULATED 2mm CANNU-FLEX DRIVER SILK SCREW 9MM CANNULATED CANNU-FLEX 7 MM X 20 MM 1 SCREW, STERILE CANNU-FLEX 7 MM X 25 MM 1 SCREW, STERILE 9 X 25 MM SOFTSILK SCREW 1.5 STERILE CANNU-FLEX 6 MM X 25 MM 1 SCREW, STERILE 7 X 25 MM SOFTSILK SCREW 1.5 STERILE CANNU-FLEX 8 MM X 25 MM 1 SCREW, STERILE CANNU-FLEX 7 MM X 30 MM 1 SCREW, STERILE

Establishment Types

Manufacture Medical Device