FDA Registration
Active
🇺🇸 United States
Cancellous Anti-Rotation Screw, 5mm x 85mm
Reg #: 2029275
·
FEI: 1000306431
·
Expires 2025
Products
1
Proprietary Names
92
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 2029275
- FEI Number
- 1000306431
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 344 Bonnie Cir
- City
- Corona
- State
- CA
- ZIP
- 92878
- Country
- US
Regulatory Submissions
- 510(k) Number
- K021008
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 |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2012-11-07 |
Proprietary Names
Cancellous Anti-Rotation Screw, 5mm x 85mm
ES Trochanteric Nail, Left, 10mm x 42cm x 130°
Captured Cortical Screw, 5mm x 36mm
Trochanteric Nail, Right, 10mm x 42cm x 130°
Trochanteric Nail, Right, 10mm x 39cm x 130°
Lag Screw, 10.5mm x 70mm
Cancellous Anti-Rotation Screw, 5mm x 70mm
Captured Cortical Screw, 5mm x 55mm
Trochanteric Nail, 9mm x 20cm x 130°
Lag Screw, 10.5mm x 110mm
Trochanteric Nail, Left, 10mm x 39cm x 130°
ES Trochanteric Nail, Right, 14mm x 33cm x 130°
Trochanteric Nail, 12mm x 20cm x 125°
Trochanteric Nail, Left, 10mm x 33cm x 130°
Lag Screw, 10.5mm x 85mm
Captured Cortical Screw, 5mm x 34mm
Cancellous Anti-Rotation Screw, 5mm x 60mm
Cancellous Anti-Rotation Screw, 5mm x 80mm
Trochanteric Nail, 10mm x 20cm x 125°
ES Trochanteric Nail, Left, 10mm x 36cm x 130°
End Cap, Bullet Tip, 10mm
Lag Screw, 10.5mm x 105mm
Trochanteric Nail, Right, 11mm x 39cm x 130°
Trochanteric Nail, 10mm x 20cm x 130°
Trochanteric Nail, Right, 10mm x 33cm x 130°
ES Trochanteric Nail, Left, 14mm x 36cm x 130°
Captured Cortical Screw, 5mm x 40mm
ES Trochanteric Nail, Right, 14mm x 39cm x 130°
Captured Cortical Screw, 5mm x 46mm
Cancellous Anti-Rotation Screw, 5mm x 90mm
ES Trochanteric Nail, Left, 11mm x 30cm x 130°
ES Trochanteric Nail, Left, 14mm x 33cm x 130°
Trochanteric Nail, Right, 10mm x 30cm x 130°
Trochanteric Nail, 13mm x 20cm x 130°
Captured Cortical Screw, 5mm x 38mm
ES Trochanteric Nail, Right, 11mm x 30cm x 130°
Captured Cortical Screw, 5mm x 32mm
Trochanteric Nail, Left, 11mm x 39cm x 130°
ES Trochanteric Nail, Right, 11mm x 39cm x 130°
Trochanteric Nail, Left, 10mm x 36cm x 130°
Captured Cortical Screw, 5mm x 42mm
Trochanteric Nail, Left, 11mm x 36cm x 130°
ES Trochanteric Nail, Left, 14mm x 39cm x 130°
Trochanteric Nail, Left, 10mm x 30cm x 130°
Trochanteric Nail, 13mm x 20cm x 125°
End Cap, Bullet Tip, 1mm
Captured Cortical Screw, 5mm x 48mm
Trochanteric Nail, Right, 10mm x 36cm x 130°
Captured Cortical Screw, 5mm x 30mm
ES Trochanteric Nail, Right, 11mm x 36cm x 130°
ES Trochanteric Nail, Right, 11mm x 42cm x 130°
Trochanteric Nail, 9mm x 20cm x 125°
Lag Screw, 10.5mm x 115mm
End Cap, Bullet Tip, 5mm
Trochanteric Nail, Left, 11mm x 42cm x 130°
Captured Cortical Screw, 5mm x 50mm
Trochanteric Nail, Right, 11mm x 33cm x 130°
ES Trochanteric Nail, Right, 10mm x 30cm x 130°
Captured Cortical Screw, 5mm x 60mm
ES Trochanteric Nail, Left, 10mm x 33cm x 130°
ES Trochanteric Nail, Left, 10mm x 30cm x 130°
Cancellous Anti-Rotation Screw, 5mm x 95mm
Captured Cortical Screw, 5mm x 44mm
Cancellous Anti-Rotation Screw, 5mm x 65mm
Lag Screw, 10.5mm x 90mm
Cancellous Anti-Rotation Screw, 5mm x 75mm
Lag Screw, 10.5mm x 120mm
ES Trochanteric Nail, Right, 10mm x 42cm x 130°
Lag Screw, 10.5mm x 100mm
ES Trochanteric Nail, Left, 10mm x 39cm x 130°
Trochanteric Nail, Left, 10mm x 42cm x 130°
ES Trochanteric Nail, Left, 11mm x 33cm x 130°
ES Trochanteric Nail, Right, 10mm x 33cm x 130°
ES Trochanteric Nail, Left, 11mm x 39cm x 130°
ES Trochanteric Nail, Right, 11mm x 33cm x 130°
ES Trochanteric Nail, Right, 10mm x 39cm x 130°
ES Trochanteric Nail, Left, 11mm x 42cm x 130°
Cancellous Anti-Rotation Screw, 5mm x 100mm
Trochanteric Nail, 12mm x 20cm x 130°
Trochanteric Nail, Right, 11mm x 36cm x 130°
Trochanteric Nail, 11mm x 20cm x 125°
Trochanteric Nail, Left, 11mm x 30cm x 130°
Lag Screw, 10.5mm x 75mm
ES Trochanteric Nail, Left, 11mm x 36cm x 130°
ES Trochanteric Nail, Right, 14mm x 36cm x 130°
Trochanteric Nail, Left, 11mm x 33cm x 130°
ES Trochanteric Nail, Right, 10mm x 36cm x 130°
Lag Screw, 10.5mm x 80mm
Trochanteric Nail, Right, 11mm x 30cm x 130°
Trochanteric Nail, 11mm x 20cm x 130°
Trochanteric Nail, Right, 11mm x 42cm x 130°
Lag Screw, 10.5mm x 95mm
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)