Identity
- Trade Name
- Dyna Locking IM Nail FDA UDI
- Generic Name
- Femur nail, non-sterile FDA UDI
- Model / Reference
- 31078 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800015935852 FDA UDI
- 510(k) Number
- K092771 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Femur nail, non-sterile 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
No
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: Femur nail, non-sterile
Dyna Locking IM Nail by CG MedTech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Femur nail, non-sterile.
- Flow-Nail™ — Flow-Fx, LLC · Class II
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- GALILEO® TROCHANTERIC NAIL, LEFT, Ø10mm x 30cm x 130° — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- AOS ANTEGRADE FEMORAL NAIL, LEFT 13mm x 46cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- AIM™FEMORAL NAIL — Biomet Orthopedics, Inc. · Class II
- Syntec Femoral Nail System — Syntec Scientific Corp. · Class II
- AOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 39cm x 125° — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- AOS ANTEGRADE FEMORAL NAIL, RIGHT 9mm x 28cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
Cleared under the same submission
K092771 also covers:
- Dyna Locking IM Nail — CG MedTech Co., Ltd.
- Dyna Locking IM Nail — CG MedTech Co., Ltd.
- Dyna Locking IM Nail — CG MedTech Co., Ltd.
- Dyna Locking IM Nail — CG MedTech Co., Ltd.
- Dyna Locking IM Nail — CG MedTech Co., Ltd.
- Dyna Locking IM Nail — CG MedTech Co., Ltd.
- Dyna Locking IM Nail — CG MedTech Co., Ltd.
- Dyna Locking IM Nail — CG MedTech Co., Ltd.
- Dyna Locking IM Nail — CG MedTech Co., Ltd.
- Dyna Locking IM Nail — CG MedTech Co., Ltd.
- Dyna Locking IM Nail — CG MedTech Co., Ltd.
- Dyna Locking IM 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CG MedTech Co., Ltd.
Sources (1)
- FDA UDI 7cf29814-e703-4331-848c-c6ac30ccdd8d 34 fields · synced May 30, 2026