Identity
- Trade Name
- FITBONE TAA SYSTEM FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, rigid FDA UDI
- Device Name
- FITBONE REAMER D10.0 L200 L480 ROUNDED FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- FITBONE REAMER D10.0 L200 L480 ROUNDED FDA UDI
Identifiers
- Catalog Number
- 60000415 FDA UDI
- Primary DI / UDI-DI
- 18053340342421 FDA UDI
- 510(k) Number
- K163368 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, rigid 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 — 10 Millimeter FDA UDILength — 200 Millimeter FDA UDILength — 480 Millimeter FDA UDI
Category: Medullary canal orthopaedic reamer, rigid
Fitbone Taa System by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medullary canal orthopaedic reamer, rigid.
- POLARSTEM — Smith & Nephew, Inc. · Class II
- Intramedullary Reamer, Revision — TOTAL JOINT ORTHOPEDICS, INC. · Class I
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- Comprehensive® Shoulder Instruments — Biomet Orthopedics, Inc. · Class II
- MP Reconstruction System - Instruments — WALDEMAR LINK GmbH & Co. KG · Class I
- Panta® 2 — Ascension Orthopedics, Inc. · Class I
- Legion — Smith & Nephew, Inc. · Class II
- INSTRUMENT — Howmedica Osteonics Corp. · 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 df5f39fc-6c71-4143-9922-78bbb6b0e39b 37 fields · synced May 30, 2026