Identity
- Trade Name
- Fuji Cervical Plate System FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, single-use FDA UDI
- Device Name
- Plate Holder FDA UDI
- Model / Reference
- 100-1030 FDA UDI
- Description
- Plate Holder FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843210133232 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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
Category: Surgical implant/trial-implant/sizer holder, single-use
Fuji Cervical Plate System by Altus Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant/trial-implant/sizer holder, single-use.
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- DynaBridge — FUSION ORTHOPEDICS, LLC · Class II
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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
- Altus Spine
Sources (1)
- FDA UDI b0114ab4-3e32-4446-b3e2-78bee9af1932 34 fields · synced May 30, 2026