Identity
- Trade Name
- CoreLink 3D Lateral Cage FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- F3D Lateral 18mm x 55mm x 12mm x 20° FDA UDI
- Model / Reference
- 3LL1855-2012 FDA UDI
- Description
- F3D Lateral 18mm x 55mm x 12mm x 20° FDA UDI
Identifiers
- Primary DI / UDI-DI
- M7253LL18552012 FDA UDI
- 510(k) Number
- K231743 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable 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
Yes
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
Radiation Sterilization FDA UDI
Category: Spinal fixation plate, non-bioabsorbable
CoreLink 3D Lateral Cage by Corelink Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K231743 also covers:
- CoreLink 3D Lateral Cage — CORELINK LLC
- CoreLink 3D Lateral Cage — CORELINK LLC
- CoreLink 3D Lateral Cage — CORELINK LLC
- CoreLink 3D Lateral Cage — CORELINK LLC
- CoreLink 3D Lateral Cage — CORELINK LLC
- CoreLink 3D Lateral Cage — CORELINK LLC
- CoreLink 3D Lateral Cage — CORELINK LLC
- CoreLink 3D Lateral Cage — CORELINK LLC
- CoreLink 3D Lateral Cage — CORELINK LLC
- CoreLink 3D Lateral Cage — CORELINK LLC
- CoreLink 3D Lateral Cage — CORELINK LLC
- CoreLink 3D Lateral Cage — CORELINK 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
- Corelink Llc
Sources (1)
- FDA UDI e7441553-7b45-455b-ae37-4e7213903f71 35 fields · synced May 30, 2026