Identity
- Trade Name
- SU-POR Surgical Implant FDA UDI
- Generic Name
- Polyethylene craniofacial tissue reconstructive material FDA UDI
- Device Name
- Sphere 16mm FDA UDI
- Model / Reference
- 4029 FDA UDI
- Description
- Sphere 16mm FDA UDI
Identifiers
- Catalog Number
- 4029 FDA UDI
- Primary DI / UDI-DI
- 00815285020243 FDA UDI
- 510(k) Number
- K140437 FDA UDI
- FDA Product Code
- FWP FDA UDIKKY FDA UDI
- GMDN Term
- Polyethylene craniofacial tissue reconstructive material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3550 FDA UDI878.3500 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
Yes
FDA UDI
MR Safe FDA UDI
SU-POR Surgical Implant by Poriferous, LLC — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Poriferous, LLC
Sources (1)
- FDA UDI d3e6f01f-5c57-4950-89a0-88a5395b4612 37 fields · synced Jun 8, 2026