Identity
- Trade Name
- AOS END CAP, HUMERAL NAIL 5mm FDA UDI
- Generic Name
- Bone nail end-cap FDA UDI
- Model / Reference
- S1074-050 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665004830 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 5mm 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.
- 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.
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 1a7095cf-801e-45d9-8962-54a26f310b1d 34 fields · synced Jun 8, 2026