Identity
- Trade Name
- Dyna Locking Ankle Nail™ FDA UDI
- Generic Name
- Arthrodesis intramedullary nail, magnetic distraction FDA UDI
- Model / Reference
- NA0924 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800015913621 FDA UDI
- 510(k) Number
- K120419 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Arthrodesis intramedullary nail, magnetic distraction FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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, magnetic distraction
Dyna Locking Ankle Nail™ by CG MedTech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Arthrodesis intramedullary nail, magnetic distraction.
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Cleared under the same submission
K120419 also covers:
- Dyna Locking Ankle Nail™ — CG MedTech Co., Ltd.
- Dyna Locking Ankle Nail™ — CG MedTech Co., Ltd.
- Dyna Locking Ankle Nail™ — CG MedTech Co., Ltd.
- Dyna Locking Ankle Nail™ — CG MedTech Co., Ltd.
- Dyna Locking Ankle Nail™ — CG MedTech Co., Ltd.
- Dyna Locking Ankle Nail™ — CG MedTech Co., Ltd.
- Dyna Locking Ankle Nail™ — CG MedTech Co., Ltd.
- Dyna Locking Ankle Nail™ — CG MedTech Co., Ltd.
- Dyna Locking Ankle Nail™ — CG MedTech Co., Ltd.
- Dyna Locking Ankle Nail™ — CG MedTech Co., Ltd.
- Dyna Locking Ankle Nail™ — CG MedTech Co., Ltd.
- Dyna Locking Ankle Nail™ — CG MedTech Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- CG MedTech Co., Ltd.
Sources (1)
- FDA UDI cc2ab85c-e269-4b46-b987-dc09d45529a7 34 fields · synced May 30, 2026