Identity
- Trade Name
- GALILEO® LAG SCREW INSERTER FDA UDI
- Generic Name
- Orthopaedic implant driver FDA UDI
- Model / Reference
- 0454-100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665023961 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic implant driver 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant driver
Galileo® Lag Screw Inserter by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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.
K120148 also covers:
- AOS GALILEO™ LAG SCREW, RIGHT, 10.5mm x 90mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SOLID LOCKING LAG SCREW 10.5mm x 100mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SOLID LOCKING LAG SCREW 10.5mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SOLID LOCKING LAG SCREW 10.5mm x 110mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SOLID LOCKING LAG SCREW 10.5mm x 115mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SOLID LOCKING LAG SCREW 10.5mm x 120mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SOLID LOCKING LAG SCREW 10.5mm x 125mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SOLID LOCKING LAG SCREW 10.5mm x 130mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SOLID LOCKING LAG SCREW 10.5mm x 135mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SOLID LOCKING LAG SCREW 10.5mm x 140mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SOLID LOCKING LAG SCREW 10.5mm x 70mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS SOLID LOCKING LAG SCREW 10.5mm x 75mm — 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 ff75bc23-2e10-461b-bc63-898d6da82447 34 fields · synced May 30, 2026