FDA Registration
Active
🇺🇸 United States
Piezosurgery Medical
Reg #: 3005282635
·
FEI: 3005282635
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Mectron North America
- Registration Number
- 3005282635
- FEI Number
- 3005282635
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4115 Leap Rd
- City
- Hilliard
- State
- OH
- ZIP
- 43026
- Country
- US
Regulatory Submissions
- 510(k) Number
- K083284
Owner / Operator
- Firm Name
- Piezosurgery, Inc DBA Mectron North America
- Operator Number
- 9075679
- Address
- 4115 Leap Road
- City
- Hilliard
- State
- OH
- Postal Code
- 43026
- Country
- US
- Correspondent
- Richelle Braun
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2013-04-29 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2013-04-29 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2013-04-29 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2013-04-29 |
| Instrument, Surgical, Sonic And Accessory/Attachment | JDX | Class 2 | Orthopedic | No | 2013-04-29 |
Proprietary Names
Piezosurgery Medical
Establishment Types
Complaint File Establishment per 21 CFR 820.198