← Back to catalogue
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 40mm
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 40mm FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- 8042-040 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665010190 FDA UDI
- 510(k) Number
- K014185 FDA UDI
- FDA Product Code
- HTN FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 40mm by Advanced Orthopaedic Solutions, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · Class II
- TMS SYSTEM — BIOMET MICROFIXATION, INC · Class II
- Flow-Screw™ — Flow-Fx, LLC · Class II
Cleared under the same submission
K014185 also covers:
- 7.0mm TAP, SMALL HUDSON — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 100mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 110mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 115mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 120mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 125mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 130mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 135mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 140mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 145mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 150mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 30mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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 (2)
- FDA UDI abb49765-28ad-40de-8423-2959e85a5945 33 fields · synced May 30, 2026
- EUDAMED 1 fields · synced May 29, 2026