FDA Registration
Active
🇺🇸 United States
SYNTHES (USA) ELECTRIC PEN DRIVE SY
Reg #: 3008812560
·
FEI: 3008812560
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Synthes (USA) Products LLC
- Registration Number
- 3008812560
- FEI Number
- 3008812560
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1301 Goshen Pkwy
- City
- West Chester
- State
- PA
- ZIP
- 19380
- Country
- US
Regulatory Submissions
- 510(k) Number
- K043310
Owner / Operator
- Firm Name
- SYNTHES (USA) Products LLC / Medical Device Business Service
- Operator Number
- 2520274
- Address
- 1301 Goshen Parkway, --
- City
- West Chester
- State
- PA
- Postal Code
- 19380
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2007-12-21 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2007-12-21 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2007-12-21 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2007-12-21 |
Proprietary Names
SYNTHES (USA) ELECTRIC PEN DRIVE SY
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility