Identity
- Trade Name
- AOS CAPTURED END CAP WITH POST 1mm FDA UDI
- Generic Name
- Bone nail end-cap FDA UDI
- Model / Reference
- S1048-019 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665004106 FDA UDI
- 510(k) Number
- K021008 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 CAPTURED END CAP WITH POST 1mm by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K021008 also covers:
- ADJUSTABLE STOP — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTI-ROTATION SCREW 5.0mm x 95mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 80mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 90mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CORTICAL SCREW 5.0mm x 100mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS TROCHANTERIC NAIL 11mm x 20cm x 125° — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS TROCHANTERIC NAIL 11mm x 20cm x 135° — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS TROCHANTERIC NAIL 12mm x 20cm x 125° — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS TROCHANTERIC NAIL, LEFT 11mm x 36cm x 130° — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS TROCHANTERIC NAIL, LEFT 12.5mm x 45cm x 130° — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS TROCHANTERIC NAIL, RIGHT 10mm x 36cm x 130° — 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 b4ff2535-2875-4a1b-b503-c191741a50ac 34 fields · synced Jun 1, 2026