Identity
- Trade Name
- AOS END CAP, HUMERAL NAIL 2mm FDA UDI
- Generic Name
- Bone nail end-cap FDA UDI
- Model / Reference
- S1074-020 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665004823 FDA UDI
- 510(k) Number
- K050241 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Bone nail end-cap FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
AOS END CAP, HUMERAL NAIL 2mm by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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.
- 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.
- AOS CANCELLOUS SCREW 5.0mm x 55.0mm — 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 868df8f7-d8a5-4157-8c1a-da3c47b9b806 34 fields · synced May 30, 2026