FDA Registration
Active
🇺🇸 United States
7 X 30 MM SOFTSILK SCREW 1.5 STERILE
Reg #: 3003604053
·
FEI: 3003604053
·
Expires 2025
Products
1
Proprietary Names
28
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SMITH & NEPHEW INC.
- Registration Number
- 3003604053
- FEI Number
- 3003604053
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ENDOSCOPY, 150 Minuteman Rd
- City
- ANDOVER
- State
- MA
- ZIP
- 01810
- 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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-01-15 |
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
Develop Specifications But Do Not Manufacture At This Facility