Identity
- Trade Name
- intellijoint HIP (R) FDA UDI
- Generic Name
- Orthopaedic stereotactic surgery system FDA UDI
- Device Name
- Intellijoint HIP Kit Lateral Platform FDA UDI
- Model / Reference
- 000-0800 FDA UDI
- Description
- Intellijoint HIP Kit Lateral Platform FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628184008003 FDA UDI
- 510(k) Number
- K191507 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic stereotactic surgery system
intellijoint HIP (R) by Intellijoint Surgical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K191507 also covers:
- intellijoint HIP (R) — Intellijoint Surgical Inc
- intellijoint HIP (R) — Intellijoint Surgical Inc
- intellijoint HIP (R) — Intellijoint Surgical Inc
- intellijoint HIP (R) — Intellijoint Surgical Inc
- intellijoint HIP (R) — Intellijoint Surgical Inc
- intellijoint HIP (R) — Intellijoint Surgical Inc
- intellijoint HIP(R) — Intellijoint Surgical Inc
- intellijoint HIP® — Intellijoint Surgical Inc
- intellijoint HIP® — Intellijoint Surgical Inc
- intellijoint HIP® — Intellijoint Surgical Inc
- intellijoint HIP® — Intellijoint Surgical Inc
- intellijoint HIP® — Intellijoint Surgical 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
- Intellijoint Surgical Inc
Sources (1)
- FDA UDI a1478df6-dea3-4de2-ac0f-a456c9fc127c 35 fields · synced May 30, 2026