Identity
- Trade Name
- Bespoke FDA UDI
- Generic Name
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
- Device Name
- Consensus MRI TKA femur guide only FDA UDI
- Model / Reference
- KNM-CO04-00-01 FDA UDI
- Description
- Consensus MRI TKA femur guide only FDA UDI
Identifiers
- Catalog Number
- KNM-CO04-00-01 FDA UDI
- Primary DI / UDI-DI
- E314KNMCO0400010 FDA UDI
- 510(k) Number
- K150928 FDA UDI
- FDA Product Code
- JWH FDA UDIMBH FDA UDIOIY FDA UDIOOG FDA UDI
- GMDN Term
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3565 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Bespoke by Materialise Usa, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Materialise Usa, L.l.c.
Sources (1)
- FDA UDI 9e9f5d44-83d0-4dd2-85e9-47a8993d332b 36 fields · synced Jun 8, 2026