Identity
- Trade Name
- Calibrated Drill, AO Style, 2.5mm x 200mm FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use, non-sterile FDA UDI
- Model / Reference
- 4016 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665028935 FDA UDI
- 510(k) Number
- K163014 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use, 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fluted surgical drill bit, single-use, non-sterile
Calibrated Drill, AO Style, 2.5mm x 200mm by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K163014 also covers:
- AOS 2.6mm Solid Reamer — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS Guide Pin, 1.5 x 230mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SBN ENTRY REAMER Ø6.1mm x 150mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SMALL BONE REAMER Ø3.1 x 328mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SMALL BONE REAMER Ø3.4 x 328mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SMALL BONE REAMER Ø3.7 x 328mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SMALL BONE REAMER Ø4.1 x 328mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SMALL BONE REAMER Ø5.1 x 328mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS T10 SCREWDRIVER, AO STYLE — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AP Connection Bolt — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Calibrated Drill, AO Style, 2.0mm x 200mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- RATCHETING SMALL AXIAL HANDLE, AO QUICK CONNECT, CANNULATED — 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 d3ceee23-74de-489f-8cf8-400def70b241 34 fields · synced May 30, 2026