Identity
- Trade Name
- FITBONE TAA SYSTEM FDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- FITBONE TUBE T13/12-L FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- FITBONE TUBE T13/12-L FDA UDI
Identifiers
- Catalog Number
- 60001055 FDA UDI
- Primary DI / UDI-DI
- 18053340343633 FDA UDI
- 510(k) Number
- K163368 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic implantation sleeve, 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
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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 13 Millimeter FDA UDILumen/Inner Diameter — 12 Millimeter FDA UDI
Category: Orthopaedic implantation sleeve, reusable
Fitbone Taa System by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic implantation sleeve, reusable.
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- SOFT TISSUE PROTECTOR HUDSON QUICK CONNECT — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
Cleared under the same submission
K163368 also covers:
- FITBONE TAA SYSTEM — Orthofix, Inc.
- FITBONE TAA SYSTEM — Orthofix, Inc.
- FITBONE TAA SYSTEM — Orthofix, Inc.
- FITBONE TAA SYSTEM — Orthofix, Inc.
- FITBONE TAA SYSTEM — Orthofix, Inc.
- FITBONE TAA SYSTEM — Orthofix, Inc.
- FITBONE TAA SYSTEM — Orthofix, Inc.
- FITBONE TAA SYSTEM — Orthofix, Inc.
- FITBONE TAA SYSTEM — Orthofix, Inc.
- FITBONE TAA SYSTEM — Orthofix, Inc.
- FITBONE TAA SYSTEM — Orthofix, Inc.
- FITBONE TAA SYSTEM — Orthofix, 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
- Orthofix, Inc.
Sources (1)
- FDA UDI 0325cc09-da34-455c-8948-130974832455 37 fields · synced Jun 8, 2026