Identity
- Trade Name
- FITBONE TAA SYSTEM FDA UDI
- Generic Name
- Orthopaedic x-ray reference grid FDA UDI
- Device Name
- FITBONE GRID PLATE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- FITBONE GRID PLATE FDA UDI
Identifiers
- Catalog Number
- 60001464 FDA UDI
- Primary DI / UDI-DI
- 18053340344050 FDA UDI
- 510(k) Number
- K163368 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic x-ray reference grid 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: Orthopaedic x-ray reference grid
Fitbone Taa System by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 03b4f9f7-024a-4ac3-8770-874e19dd5dc2 36 fields · synced Jun 8, 2026