Identity
- Trade Name
- GALAXY FIXATION SYSTEM FDA UDI
- Generic Name
- Orthopaedic trocar blade, reusable FDA UDI
- Device Name
- TAPERED TROCAR FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- TAPERED TROCAR FDA UDI
Identifiers
- Catalog Number
- 19965 FDA UDI
- Primary DI / UDI-DI
- 18033509859960 FDA UDI
- 510(k) Number
- K113770 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- Orthopaedic trocar blade, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
Category: Orthopaedic trocar blade, reusable
Galaxy Fixation System by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic trocar blade, reusable.
- Trauma Fixation Systems — Biomet Orthopedics, Inc. · Class I
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- EBA ONE — Citieffe · Class II
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- ARTHROLUTION — Richard Wolf GmbH · Class I
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Cleared under the same submission
K113770 also covers:
- GALAXY FIXATION GEMINI — Orthofix, Inc.
- GALAXY FIXATION GEMINI — Orthofix, Inc.
- GALAXY FIXATION GEMINI — Orthofix, Inc.
- GALAXY FIXATION GEMINI — Orthofix, Inc.
- GALAXY FIXATION SYSTEM — Orthofix, Inc.
- GALAXY FIXATION SYSTEM — Orthofix, Inc.
- GALAXY FIXATION SYSTEM — Orthofix, Inc.
- GALAXY FIXATION SYSTEM — Orthofix, Inc.
- GALAXY FIXATION SYSTEM — Orthofix, Inc.
- GALAXY FIXATION SYSTEM — Orthofix, Inc.
- GALAXY FIXATION SYSTEM — Orthofix, Inc.
- GALAXY FIXATION 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 29b4b397-ce17-4736-92f1-cd734eb7f06c 36 fields · synced May 30, 2026