Identity
- Trade Name
- IMPIX 3D Print FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- TLIF-B (C) 3DP 08x06°x28x10 FDA UDI
- Model / Reference
- B242C08062810 FDA UDI
- Description
- TLIF-B (C) 3DP 08x06°x28x10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03613720270508 FDA UDI
- 510(k) Number
- K163595 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Metallic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
IMPIX 3D Print by Medicrea International SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K163595 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
- Medicrea International SA
Sources (1)
- FDA UDI 1b951971-b79f-417d-a7ea-bb4a865312e0 35 fields · synced Jun 8, 2026