← Back to catalogue
Activmotion S DTO
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref FTPS1-ST510(k) K241539
Identity
- Trade Name
- Activmotion S DTO FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Activmotion S DTO EUDAMED
- Model / Reference
- FTPS1-ST EUDAMEDFDA UDI
Identifiers
- Catalog Number
- FTPS1-ST FDA UDI
- Primary DI / UDI-DI
- 03700569629564 EUDAMEDFDA UDI
- Basic UDI-DI
- 3700569600158V EUDAMED
- 510(k) Number
- K202803 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Activmotion S DTO by Newclip Technics SAS — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241539 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K202803 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 3700569600158V | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Newclip Technics SAS
- EUDAMED SRN
- FR-MF-000011809
- FDA Applicant
- Newclip Technics
Sources (3)
- EUDAMED 58bce115-c25d-4766-abb2-293f1bba3398 85 fields · synced Jun 18, 2026
- FDA UDI ef45060a-37e5-4c73-8878-5d920e68f939 34 fields · synced May 29, 2026
- FDA 510(k) K241539 1 fields · synced May 18, 2026