Identity
- Trade Name
- DJO SURGICAL FDA UDI
- Generic Name
- Osteotomy guide, reusable FDA UDI
- Device Name
- GUIDE, TIBIAL RESECTION EXTRAMEDULLARY TYPE II R FDA UDI
- Model / Reference
- 801-01-265 FDA UDI
- Description
- GUIDE, TIBIAL RESECTION EXTRAMEDULLARY TYPE II R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888912128599 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Osteotomy guide, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
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
Yes
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: Osteotomy guide, reusable
The DJO Surgical Guide is a high-quality, reusable osteotomy guide designed for surgeons to outline and define the desired cut-line during joint arthroplasty procedures. Engineered with precision and accuracy, this instrument provides exceptional support and stability, making it an ideal tool for complex surgical procedures.
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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 |
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Manufacturer
- Manufacturer
- Djo, Llc
Sources (1)
- FDA UDI 7f25c582-79db-4805-892d-56bac2818b0f 33 fields · synced Jun 22, 2026