Identity
- Trade Name
- Talon™ Compression Hip Screw System FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Side Plate, 135 Deg x 38mm, Standard Barrel, 4 Hole FDA UDI
- Model / Reference
- THS135384 FDA UDI
- Description
- Side Plate, 135 Deg x 38mm, Standard Barrel, 4 Hole FDA UDI
Identifiers
- Primary DI / UDI-DI
- B058THS1353841 FDA UDI
- 510(k) Number
- K984331 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
- Angle — 135 degree FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Talon™ Compression Hip Screw System by Orthopedic Designs North America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable, non-sterile.
- CANNULATED SCREW SYSTEM — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
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- ORTHOLOC — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Summa Orthopaedics Wrist System Bone Plate — Jeil Medical Corporation · Class II
- Summa Orthopaedics Foot System Bone Plate — Jeil Medical Corporation · Class II
- SAMPEDRO — Industrias Medicas Sampedro S.A.S · Class II
- TUBULAR PLATE — Biomet Orthopedics, Inc. · Class II
- APTUS — Medartis Inc. · Class II
Cleared under the same submission
K984331 also covers:
- Talon™ Compression Hip Screw System — Orthopedic Designs North America, Inc.
- Talon™ Compression Hip Screw System — Orthopedic Designs North America, Inc.
- Talon™ Compression Hip Screw System — Orthopedic Designs North America, Inc.
- Talon™ Compression Hip Screw System — Orthopedic Designs North America, Inc.
- Talon™ Compression Hip Screw System — Orthopedic Designs North America, Inc.
- Talon™ Compression Hip Screw System — Orthopedic Designs North America, Inc.
- Talon™ Compression Hip Screw System — Orthopedic Designs North America, Inc.
- Talon™ Compression Hip Screw System — Orthopedic Designs North America, Inc.
- Talon™ Compression Hip Screw System — Orthopedic Designs North America, Inc.
- Talon™ Compression Hip Screw System — Orthopedic Designs North America, Inc.
- Talon™ Compression Hip Screw System — Orthopedic Designs North America, Inc.
- Talon™ Compression Hip Screw System — 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 0c7a0d62-0dee-4bc7-8313-88c4c0d8da0f 36 fields · synced Jun 1, 2026