Identity
- Trade Name
- Distal Lateral Tibial Locking Plate, Combi-holes FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Model / Reference
- 020461008 FDA UDI
Identifiers
- Catalog Number
- 020461008 FDA UDI
- Primary DI / UDI-DI
- 06942782479565 FDA UDI
- 510(k) Number
- K130108 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Width — 13.0 Millimeter FDA UDILength — 148.0 Millimeter FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
Distal Lateral Tibial Locking Plate, Combi-holes by Double Medical Technology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- AXSOS — Stryker Corp. · Class II
- Xpert Wrist — NEWCLIP TECHNICS · Class II
- ACUMED — ACUMED LLC · Class II
- Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Cleared under the same submission
K130108 also covers:
- 1.5S-Mini Screw — Double Medical Technology Inc.
- 2.0S-Mini Screw — Double Medical Technology Inc.
- 2.4mm Locking Screw — Double Medical Technology Inc.
- 2.7S-Mini Locking Screw — Double Medical Technology Inc.
- 2.7S-Mini Screw — Double Medical Technology Inc.
- 2.7S-Mini Screw — Double Medical Technology Inc.
- 2.7S-Mini Screw — Double Medical Technology Inc.
- 3.5mm Locking Screw, Self-drilling — Double Medical Technology Inc.
- 4.0mm Cancellous Screw, Fully Threaded — Double Medical Technology Inc.
- 5.0mm Locking screw, Self-drilling — Double Medical Technology Inc.
- 5.0mm Locking screw, Self-drilling — Double Medical Technology Inc.
- 5.0mm Locking screw, Self-tapping — Double Medical Technology Inc.
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
- Double Medical Technology Inc.
Sources (1)
- FDA UDI 044c76d2-4a3a-47a0-935e-cc2f3134825b 36 fields · synced Jun 6, 2026