Identity
- Trade Name
- Phantom Plus Cage System FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- Cervical Inserter FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Cervical Inserter FDA UDI
Identifiers
- Catalog Number
- 33-1000-001 FDA UDI
- Primary DI / UDI-DI
- M555331000001 FDA UDI
- FDA Product Code
- MAX FDA UDIODP FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
The Phantom Plus Cage System is a hand-held, reusable instrument designed to connect and hold implants in cervical spine surgery. This device provides precise guidance and sizing for various orthopedic procedures.
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
- Amedica Corp.
Sources (1)
- FDA UDI 894f833b-6e39-4b1e-8fd3-93c24a57c681 36 fields · synced Jul 19, 2026