Identity
- Trade Name
- DRACO FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Device Name
- DRACO MetaFuse L-Plate, Ti - (L)28mm, R FDA UDI
- Model / Reference
- HTR-03-010728 FDA UDI
- Description
- DRACO MetaFuse L-Plate, Ti - (L)28mm, R FDA UDI
Identifiers
- Catalog Number
- HTR-03-010728 FDA UDI
- Primary DI / UDI-DI
- 00841742121789 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: External orthopaedic fixation system, single-use
Draco by Hnm Total Recon Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, single-use.
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- ARBOR — GLOBUS MEDICAL, INC. · Class II
- PREFIX FIXATOR — Orthofix, Inc. · Class II
- RINGFIX — Stryker Corp. · Class II
- SMART TSF — Smith & Nephew, Inc. · Class II
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
- Hnm Total Recon Llc
Sources (1)
- FDA UDI 149be42f-cd32-453e-8eb9-33a0e985e77a 34 fields · synced Jun 6, 2026