Identity
- Trade Name
- FITBONE TAA SYSTEM FDA UDI
- Generic Name
- Surgical torque wrench, reusable FDA UDI
- Device Name
- FITBONE OPEN END WRENCH SW14/17 FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- FITBONE OPEN END WRENCH SW14/17 FDA UDI
Identifiers
- Catalog Number
- 60000689 FDA UDI
- Primary DI / UDI-DI
- 18053340342759 FDA UDI
- 510(k) Number
- K163368 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Surgical torque wrench, 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
Category: Surgical torque wrench, 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 Surgical torque wrench, reusable.
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- OXFORD ANKLE FUSION NAIL(AFN) SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED · Class II
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- BIONNOVATION — BIONNOVATION PRODUTOS BIOMEDICOS LTDA. · 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 366008d3-903c-46c8-abbb-9489567e8d35 37 fields · synced Jun 8, 2026