Identity
- Trade Name
- Golden Spike FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- 4.5 x 40mm trauma screw FDA UDI
- Model / Reference
- OM-TLS4540 FDA UDI
- Description
- 4.5 x 40mm trauma screw FDA UDI
Identifiers
- Catalog Number
- OM-TLS4540 FDA UDI
- Primary DI / UDI-DI
- 00843511100735 FDA UDI
- 510(k) Number
- K192096 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.5 Millimeter FDA UDILength — 40 Millimeter FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
Golden Spike by Omnia Medical — 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
K192096 also covers:
- Golden Spike — Omnia Medical
- Golden Spike — Omnia Medical
- Golden Spike — Omnia Medical
- Omnia Medical Golden Spike — Omnia Medical
- Omnia Medical Golden Spike — Omnia Medical
- Omnia Medical Golden Spike — Omnia Medical
- Omnia Medical Golden Spike — Omnia Medical
- Omnia Medical Golden Spike — Omnia Medical
- Omnia Medical Golden Spike — Omnia Medical
- Omnia Medical Golden Spike — Omnia Medical
- Omnia Medical Golden Spike — Omnia Medical
- Omnia Medical Golden Spike — Omnia Medical
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
- Omnia Medical
Sources (1)
- FDA UDI 8470c607-baeb-44f8-9a82-b72994baa7e3 37 fields · synced May 31, 2026