Identity
- Trade Name
- Bespoke FDA UDI
- Generic Name
- Custom-made organ/bone anatomy model/surgical guide kit FDA UDI
- Device Name
- Consensus CT THA guides and bone models FDA UDI
- Model / Reference
- HPC-CO01-00-01 FDA UDI
- Description
- Consensus CT THA guides and bone models FDA UDI
Identifiers
- Catalog Number
- HPC-CO01-00-01 FDA UDI
- Primary DI / UDI-DI
- E314HPCCO010001 FDA UDI
- 510(k) Number
- K150780 FDA UDI
- FDA Product Code
- PLW FDA UDI
- GMDN Term
- Custom-made organ/bone anatomy model/surgical guide kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 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
K150780 also covers:
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 3546a269-5c2c-4eef-bca8-8bd828938f25 36 fields · synced Jun 6, 2026