Identity
- Trade Name
- AUDERE C CORPECTOMY IMPLANT 48 MM X 6° FDA UDI
- Generic Name
- Ceramic spinal interbody fusion cage FDA UDI
- Device Name
- THE AUDERE C SPINAL INTERVETEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVETEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE INVERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY. FDA UDI
- Model / Reference
- 41480006 FDA UDI
- Description
- THE AUDERE C SPINAL INTERVETEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVETEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE INVERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY. FDA UDI
Identifiers
- Catalog Number
- 41480006 FDA UDI
- Primary DI / UDI-DI
- 00819824020374 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Ceramic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Height — 48 Millimeter FDA UDIAngle — 6 degree FDA UDI
Category: Ceramic spinal interbody fusion cage
Audere C Corpectomy Implant 48 Mm X 6° by Met 1 Technologies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Met 1 Technologies, Llc
Sources (1)
- FDA UDI 58096de3-f2e2-471e-8ec0-a769ee3f9e48 36 fields · synced May 31, 2026