Identity
- Trade Name
- Dual Core Cortical Locking Screw FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Dual Core Cortical Locking Screw - Ø4mm x 54mm FDA UDI
- Model / Reference
- HTNU454 FDA UDI
- Description
- Dual Core Cortical Locking Screw - Ø4mm x 54mm FDA UDI
Identifiers
- Catalog Number
- HTN-U-4-54 FDA UDI
- Primary DI / UDI-DI
- B058HTNU4541 FDA UDI
- 510(k) Number
- K173255 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 54 Millimeter FDA UDIOuter Diameter — 4 Millimeter FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
Dual Core Cortical Locking Screw by Orthopedic Designs North America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Monster Screw System — Paragon 28 · Class II
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · Class II
Cleared under the same submission
K173255 also covers:
- Dual Core Cortical Locking Screw — Orthopedic Designs North America, Inc.
- Dual Core Cortical Locking Screw — Orthopedic Designs North America, Inc.
- Dual Core Cortical Locking Screw — Orthopedic Designs North America, Inc.
- Dual Core Cortical Locking Screw — Orthopedic Designs North America, Inc.
- Dual Core Cortical Locking Screw — Orthopedic Designs North America, Inc.
- Dual Core Cortical Locking Screw — Orthopedic Designs North America, Inc.
- Dual Core Cortical Locking Screw — Orthopedic Designs North America, Inc.
- Dual Core Cortical Locking Screw — Orthopedic Designs North America, Inc.
- Dual Core Cortical Locking Screw — Orthopedic Designs North America, Inc.
- Dual Core Cortical Locking Screw — Orthopedic Designs North America, Inc.
- Dual Core Cortical Locking Screw — Orthopedic Designs North America, Inc.
- Dual Core Cortical Locking Screw — Orthopedic Designs North America, 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
- Orthopedic Designs North America, Inc.
Sources (1)
- FDA UDI b07ea232-ce57-4307-8c1f-aa787a79c6f8 37 fields · synced Jun 1, 2026