Identity
- Trade Name
- intellijoint HIP® FDA UDI
- Generic Name
- Orthopaedic stereotactic surgery system FDA UDI
- Device Name
- Femoral Disc, Nails, G2 FDA UDI
- Model / Reference
- 000-0356 FDA UDI
- Description
- Femoral Disc, Nails, G2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628184003565 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Orthopaedic stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
MR Unsafe FDA UDI
Category: Orthopaedic stereotactic surgery system
intellijoint HIP® by Intellijoint Surgical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Intellijoint Surgical Inc
Sources (1)
- FDA UDI 1a3f8964-ab75-4188-a6a2-d5572991d1f9 34 fields · synced Jun 6, 2026