Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- Screws associated to plates EUDAMED
- Model / Reference
- SDT2.4L30-ST EUDAMEDFDA UDI
Identifiers
- Catalog Number
- SDT2.4L30-ST FDA UDI
- Primary DI / UDI-DI
- 03700569625610 EUDAMEDFDA UDI
- Basic UDI-DI
- 37005696001893 EUDAMED
- 510(k) Number
- K170843 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P09120602 CANCELLOUS SCREWS EUDAMED
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Screws associated to plates are a medical device designed for use in orthopedic and dental applications. These devices are typically used in conjunction with surgical implants or prosthetic devices, such as plates, screws, and rods. The Screws associated to plates provide a secure and stable fixation of these devices, allowing for optimal healing and bone growth.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 37005696001893 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Newclip Technics SAS
- EUDAMED SRN
- FR-MF-000011809
Sources (2)
- EUDAMED 4fcc15a9-09d3-40e0-ab8e-0b1f65a3ead6 61 fields · synced Jun 24, 2026
- FDA UDI 27fa30a9-7577-4e2f-9e95-ae79aacfc544 34 fields · synced May 30, 2026