Identity
- Trade Name
- Dyna Locking Trochanteric Nail™ EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- LOCKING SCREW - 5.0 X 82.5 mm EUDAMED
- Model / Reference
- 32142 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800037551450 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800037551450 EUDAMED
- 510(k) Number
- K093707 FDA UDI
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS EUDAMED
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Market of Registration
- Greece EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Arthrodesis intramedullary nail, non-distracting
Dyna Locking Trochanteric Nail™ by CG MedTech Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800037551450 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- CG MedTech Co., Ltd.
- EUDAMED SRN
- KR-MF-000035461
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED f6c1b3e7-8725-47b4-89f5-3d98c51ef423 61 fields · synced Oct 6, 2026
- FDA UDI 64311b52-1deb-4eb4-81d5-6b13eaa1d3b7 33 fields · synced May 30, 2026