Identity
- Trade Name
- CONCORDE FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- CONCORDE BULLET SPINAL SYSTEM LORDOTIC CAGE 9 x 11 x 27mm FDA UDI
- Model / Reference
- 196927511 FDA UDI
- Description
- CONCORDE BULLET SPINAL SYSTEM LORDOTIC CAGE 9 x 11 x 27mm FDA UDI
Identifiers
- Catalog Number
- 196927511 FDA UDI
- Primary DI / UDI-DI
- 10705034454375 FDA UDI
- FDA Product Code
- MQP FDA UDIMAX FDA UDI
- GMDN Term
- Metallic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3080 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Metallic spinal interbody fusion cage
Concorde by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K151352 also covers:
- CONCORDE — Medos International Sàrl
- CONCORDE — Medos International Sàrl
- CONCORDE — Medos International Sàrl
- CONCORDE — Medos International Sàrl
- CONCORDE — Medos International Sàrl
- CONCORDE — Medos International Sàrl
- CONCORDE — Medos International Sàrl
- CONCORDE — Medos International Sàrl
- CONCORDE — Medos International Sàrl
- CONCORDE — Medos International Sàrl
- CONCORDE — Medos International Sàrl
- CONCORDE — Medos International Sàrl
K173787 also covers:
- BENGAL — Depuy Spine, Inc.
- BENGAL — Depuy Spine, Inc.
- BENGAL — Depuy Spine, Inc.
- BENGAL — Depuy Spine, Inc.
- BENGAL — Depuy Spine, Inc.
- BENGAL — Depuy Spine, Inc.
- BENGAL — Depuy Spine, Inc.
- COUGAR — Depuy Spine, Inc.
- COUGAR — Depuy Spine, Inc.
- COUGAR — Depuy Spine, Inc.
- COUGAR — Depuy Spine, Inc.
- COUGAR — Depuy Spine, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medos International Sàrl
Sources (1)
- FDA UDI 12ed9ff4-5568-47f6-af64-42b4c2294306 36 fields · synced May 31, 2026