Identity
- Trade Name
- ZEUS-P FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- Zeus-P Hollow Case, 25L x 13W x 16mm, 5.7 Degree FDA UDI
- Model / Reference
- PH251316 FDA UDI
- Description
- Zeus-P Hollow Case, 25L x 13W x 16mm, 5.7 Degree FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840916123482 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Polymeric 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Zeus-P by Spinal Elements, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Spinal Elements, Inc.
Sources (1)
- FDA UDI a5c8f954-aa7b-4a61-a618-ec16f8075e78 34 fields · synced May 31, 2026