Identity
- Trade Name
- AUDERE POSTERIOR LUMBAR SPACER SYSTEM FDA UDI
- Generic Name
- Ceramic spinal interbody fusion cage FDA UDI
- Device Name
- THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AUDERE LUMBAR SPACER SYSTEM MAY BE IMPLANTED BILATERALLY USING A POSTERIOR (PLIF) APPROACH, OR A SINGLE DEVICE EMPLOYING A TRANSFORAMINAL (TLIF) APPROACH. FDA UDI
- Model / Reference
- 30290151 FDA UDI
- Description
- THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AUDERE LUMBAR SPACER SYSTEM MAY BE IMPLANTED BILATERALLY USING A POSTERIOR (PLIF) APPROACH, OR A SINGLE DEVICE EMPLOYING A TRANSFORAMINAL (TLIF) APPROACH. FDA UDI
Identifiers
- Catalog Number
- 30290151 FDA UDI
- Primary DI / UDI-DI
- 00819824020824 FDA UDI
- 510(k) Number
- K160699 FDA UDI
- FDA Product Code
- MAX 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
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ceramic spinal interbody fusion cage
Audere Posterior Lumbar Spacer System by Met 1 Technologies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K160699 also covers:
- AUDERE POSTERIOR LUMBAR SPACER SYSTEM — MET 1 TECHNOLOGIES, LLC
- AUDERE POSTERIOR LUMBAR SPACER SYSTEM — MET 1 TECHNOLOGIES, LLC
- AUDERE POSTERIOR LUMBAR SPACER SYSTEM — MET 1 TECHNOLOGIES, LLC
- AUDERE POSTERIOR LUMBAR SPACER SYSTEM — MET 1 TECHNOLOGIES, LLC
- AUDERE POSTERIOR LUMBAR SPACER SYSTEM — MET 1 TECHNOLOGIES, LLC
- AUDERE POSTERIOR LUMBAR SPACER SYSTEM — MET 1 TECHNOLOGIES, LLC
- AUDERE POSTERIOR LUMBAR SPACER SYSTEM — MET 1 TECHNOLOGIES, LLC
- AUDERE POSTERIOR LUMBAR SPACER SYSTEM — MET 1 TECHNOLOGIES, LLC
- AUDERE POSTERIOR LUMBAR SPACER SYSTEM — MET 1 TECHNOLOGIES, LLC
- AUDERE POSTERIOR LUMBAR SPACER SYSTEM — MET 1 TECHNOLOGIES, LLC
- AUDERE POSTERIOR LUMBAR SPACER SYSTEM — MET 1 TECHNOLOGIES, LLC
- AUDERE POSTERIOR LUMBAR SPACER SYSTEM — MET 1 TECHNOLOGIES, LLC
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 fc640740-41fd-4957-a04b-d516105f4474 36 fields · synced Jun 6, 2026