Identity
- Trade Name
- GALILEO EXTRACTION TOOL, CAPTURING ROD NUT FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Model / Reference
- 0858-200 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665030907 FDA UDI
- 510(k) Number
- K021008 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Implantable bone washer 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Implantable bone washer
Galileo Extraction Tool, Capturing Rod Nut by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- FLAT WASHER — Biomet Orthopedics, Inc. · Class II
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- LEOS Cannulated Screw System — Tyber Medical · Class II
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 07f3e6f1-2285-4f77-8744-1415b02b86c0 34 fields · synced May 30, 2026