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CoreLink Foundation 3D ALIF Stand-Alone Screw
FDA UDIClass II (US FDA UDI)
by Corelink Llc
Identity
- Trade Name
- CoreLink Foundation 3D ALIF Stand-Alone Screw FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- Foundation 3D Stand Alone Screw-ALIF, Fixed Self Tapping, 5.5mm x 20mm FDA UDI
- Model / Reference
- 10555-20 FDA UDI
- Description
- Foundation 3D Stand Alone Screw-ALIF, Fixed Self Tapping, 5.5mm x 20mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- M7251055520 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile 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
No
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: Bone-screw internal spinal fixation system, non-sterile
CoreLink Foundation 3D ALIF Stand-Alone Screw by Corelink Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system, non-sterile.
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- SILVERTON SPINAL FIXATION SYSTEM — BIOMET SPINE LLC · Class II
- POLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLC · Class II
- Vitality® — BIOMET SPINE LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- PASS LP — Medicrea International SA · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- ALTA STAND-ALONE INTERBODY FUSION SYSTEM — BIOMET SPINE LLC · Class II
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 3e036dfc-a940-4f2d-908e-3e821d359cc1 34 fields · synced May 30, 2026