Identity
- Trade Name
- 5.0mm HEX DRIVER, AO STYLE FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Model / Reference
- 5001-100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665040142 FDA UDI
- 510(k) Number
- K202489 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Surgical screwdriver, reusable 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
No
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
Category: Surgical screwdriver, reusable
5.0mm HEX DRIVER, AO STYLE by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical screwdriver, reusable.
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- USS — Synthes · Class I
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Cleared under the same submission
K202489 also covers:
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 100mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 10mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 14mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 16mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 26mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 28mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 30mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 34mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 40mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 42mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 48mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 50mm — ADVANCED ORTHOPAEDIC SOLUTIONS, 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
- Advanced Orthopaedic Solutions, Inc.
Sources (1)
- FDA UDI 4e09f9f8-b4e9-4714-a58d-26f9cb3dcb02 34 fields · synced May 30, 2026