Identity
- Trade Name
- CONCORDE FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- CONCORDE CURVE SPINAL SYSTEM PARALLEL 0 DEGREES, 30 x 12mm FDA UDI
- Model / Reference
- 187500112 FDA UDI
- Description
- CONCORDE CURVE SPINAL SYSTEM PARALLEL 0 DEGREES, 30 x 12mm FDA UDI
Identifiers
- Catalog Number
- 187500112 FDA UDI
- Primary DI / UDI-DI
- 10705034138046 FDA UDI
- 510(k) Number
- K101923 FDA UDI
- FDA Product Code
- MAX FDA UDIMQP FDA UDI
- GMDN Term
- Polymeric spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI888.3060 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Concorde by Medos International Sàrl — 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
- Medos International Sàrl
Sources (1)
- FDA UDI 638f6be0-92cc-4e65-b213-6ba4447c70c7 37 fields · synced Jun 1, 2026