Identity
- Trade Name
- CAPTURING ROD, GALILEO® LAG SCREW FDA UDI
- Generic Name
- Orthopaedic instrument surgical connector FDA UDI
- Model / Reference
- 0455-100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665021455 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic instrument surgical connector 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 instrument surgical connector
Capturing Rod, Galileo® Lag Screw by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic instrument surgical connector.
- Surgical Instrument — Jeil Medical Corporation · Class I
- Maxim® Instrumentation — Biomet Orthopedics, Inc. · Class I
- QUANTUM — IN2BONES · Class I
- KINCISE™ System Acetabular Cup Extraction SST Head 28mm — Spierings Orthopaedics B.V. · Class I
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- Pilot Spinal System — Life Spine, Inc. · Class II
- MIS Curved Rod, Ø5.5 x 85mm — Captiva Spine · 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.
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 98364ed9-cc5a-4270-b6a1-5cd832d50073 34 fields · synced May 31, 2026