Identity
- Trade Name
- CORTICAL SCREW 3.5mm x 40.0mm FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- 8010-400 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665019773 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
CORTICAL SCREW 3.5mm x 40.0mm by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
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Cleared under the same submission
K050241 also covers:
- 10.5mm CANNULATED ENTRY REAMER — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- 2.5mm HEX SCREWDRIVER — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- 3.5mm HEX SCREWDRIVER — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 20.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 22.5mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 32.5mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 37.5mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 40.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 42.5mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 45.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 47.5mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 50.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
K080590 also covers:
- 95° PROXIMAL HUMERAL PLATE 5 HOLE — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LOCKING SCREW 4.0mm x 24mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LOCKING SCREW 4.0mm x 34mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LOCKING SCREW 4.0mm x 36mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LOCKING SCREW 4.0mm x 44mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LOCKING SCREW 4.0mm x 50mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LOCKING SCREW 4.0mm x 52mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 20mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 22mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 30mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 32mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 34mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
K090478 also covers:
- AOS CORTICAL SCREW 3.5mm x 10.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS Drill, AO Style, 2.9mm x 100mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 7.0mm x 22.5cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 7.0mm x 25cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 7.0mm x 27.5cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 7.0mm x 32.5cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 8.0mm x 20cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 8.0mm x 22.5cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 8.0mm x 25cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 8.0mm x 27.5cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 8.0mm x 30cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 9.0mm x 22.5cm — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Orthopaedic Solutions, Inc.
Sources (1)
- FDA UDI 7bd8f684-c2cc-4bb8-ace8-43fd6162201d 33 fields · synced Jun 1, 2026