Identity
- Trade Name
- T-HANDLE SPACER FDA UDI
- Generic Name
- Surgical instrument guard, reusable FDA UDI
- Model / Reference
- 5045-000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665037814 FDA UDI
- 510(k) Number
- K202099 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Surgical instrument guard, reusable 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
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: Surgical instrument guard, reusable
T-Handle Spacer 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
K202099 also covers:
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- CAPTURING ROD NUT, GALILEO® LAG SCREW — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- CAPTURING ROD, GALILEO® LAG SCREW — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- CAPTURING ROD, GALILEO® LAG SCREW — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- COMPRESSION SLEEVE — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- GALILEO® CAPTURING ROD WRENCH — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- GALILEO® CRT²™ LAG SCREW, RIGHT, 10.5mm x 100mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- GALILEO® CRT²™ LAG SCREW, RIGHT, 10.5mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- GALILEO® CRT²™ LAG SCREW, RIGHT, 10.5mm x 110mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- GALILEO® CRT²™ LAG SCREW, RIGHT, 10.5mm x 115mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- GALILEO® CRT²™ LAG SCREW, RIGHT, 10.5mm x 120mm — 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 7a00ef92-6f0e-4130-adb6-345958cfa70e 34 fields · synced Jun 8, 2026