Identity
- Trade Name
- PointCloud Knee Instruments FDA UDI
- Generic Name
- Total knee prosthesis implantation guide-instrument kit FDA UDI
- Device Name
- UNIKO PointCloud Knee Instrument Kit FDA UDI
- Model / Reference
- UKI0201-L FDA UDI
- Description
- UNIKO PointCloud Knee Instrument Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- TKRL00013K190 FDA UDI
- 510(k) Number
- K240327 FDA UDI
- FDA Product Code
- MBH FDA UDIJWH FDA UDIOOG FDA UDI
- GMDN Term
- Total knee prosthesis implantation guide-instrument kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3565 FDA UDI888.3560 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Total knee prosthesis implantation guide-instrument kit
PointCloud Knee Instruments by Unik Orthopedics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K240327 also covers:
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, INC
- PointCloud Knee Instruments — UNIK ORTHOPEDICS, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Unik Orthopedics, Inc
Sources (1)
- FDA UDI 484a8482-afd6-434a-ad44-6fb5b155643b 34 fields · synced Jun 8, 2026