Identity
- Trade Name
- TransLoc 3D FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Retraction Guide Tube FDA UDI
- Model / Reference
- S02-01 FDA UDI
- Description
- Retraction Guide Tube FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850026642124 FDA UDI
- 510(k) Number
- K211496 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic surgical procedure kit, non-medicated, reusable
TransLoc 3D by Foundation Fusion Solutions, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K211496 also covers:
- TransLoc 3D — FOUNDATION FUSION SOLUTIONS, LLC
- TransLoc 3D — FOUNDATION FUSION SOLUTIONS, LLC
- TransLoc 3D — FOUNDATION FUSION SOLUTIONS, LLC
- TransLoc 3D — FOUNDATION FUSION SOLUTIONS, LLC
- TransLoc 3D — FOUNDATION FUSION SOLUTIONS, LLC
- TransLoc 3D — FOUNDATION FUSION SOLUTIONS, LLC
- TransLoc 3D — FOUNDATION FUSION SOLUTIONS, LLC
- TransLoc 3D — FOUNDATION FUSION SOLUTIONS, LLC
- TransLoc 3D — FOUNDATION FUSION SOLUTIONS, LLC
- TransLoc 3D — FOUNDATION FUSION SOLUTIONS, LLC
- TransLoc 3D — FOUNDATION FUSION SOLUTIONS, LLC
- TransLoc 3D — FOUNDATION FUSION SOLUTIONS, LLC
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Foundation Fusion Solutions, Llc
Sources (1)
- FDA UDI 7ff59236-08c6-4bc4-ab8a-c31dcd83f113 35 fields · synced Jun 8, 2026