FDA Registration
Active
🇫🇷 France
NOVASTEP
Reg #: 3010673777
·
FEI: 3010673777
·
Expires 2026
Products
8
Proprietary Names
13
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- NOVASTEP
- Registration Number
- 3010673777
- FEI Number
- 3010673777
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2 allee Jacques Frimot
- City
- RENNES Bretagne
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K151277
Owner / Operator
- Firm Name
- NOVASTEP
- Operator Number
- 10048280
- Address
- 2 allee Jacques Frimot
- City
- RENNES
- State
- Bretagne
- Postal Code
- 35000
- Country
- FR
- Correspondent
- Manon Dupleichs
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2015-08-18 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-12-24 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2026-04-03 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2014-12-23 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2023-05-25 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2014-12-24 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2015-02-20 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2018-05-15 |
Proprietary Names
Airlock Plating System
Centrolock Guided Transverse Osteotomy System
Novastep Orthopedic Manual Surgical Instrument
Airlock® Ankle Plating System
Arcad Staples; eXpress Staples
Nexis Rearfoot Screws
Novastep Guide
arcad® 2 Duo & Quadro Osteosynthesis Compressive Staple
Novastep Surgical Instrument and Attachment
Lync Hammertoe Correction System
Nexis Cannulated Screws
Nexis Snap-Off Screws
Novastep Tray
Establishment Types
Manufacture Medical Device