Identity
- Trade Name
- StabiLink®MIS Spinal Fixation System FDA UDI
- Generic Name
- Interspinous spinal fixation implant FDA UDI
- Device Name
- C2 Base, Locking Device, 10mm FDA UDI
- Model / Reference
- CBL-10 FDA UDI
- Description
- C2 Base, Locking Device, 10mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815351020504 FDA UDI
- 510(k) Number
- K123093 FDA UDI
- FDA Product Code
- KWP FDA UDI
- GMDN Term
- Interspinous spinal fixation implant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 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: Interspinous spinal fixation implant
A comprehensive spinal fixation system for minimally invasive thoracic, lumbar, or sacral spine procedures. Stabilize and immobilize spinal segments with the StabiLink MIS Spinal Fixation System.
Similar devices
Also classified as Interspinous spinal fixation implant.
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
- ASPEN MIS FUSION SYSTEM — BIOMET SPINE LLC · Class II
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
- InFill V2 Lateral PE — PINNACLE SPINE GROUP, LLC · Class II
Cleared under the same submission
K123093 also covers:
- StabiLink®MIS Spinal Fixation System — Southern Spine LLC
- StabiLink®MIS Spinal Fixation System — Southern Spine LLC
- StabiLink®MIS Spinal Fixation System — Southern Spine LLC
- StabiLink®MIS Spinal Fixation System — Southern Spine LLC
- StabiLink®MIS Spinal Fixation System — Southern Spine LLC
- StabiLink®MIS Spinal Fixation System — Southern Spine LLC
- StabiLink®MIS Spinal Fixation System — Southern Spine LLC
- StabiLink®MIS Spinal Fixation System — Southern Spine LLC
- StabiLink®MIS Spinal Fixation System — Southern Spine LLC
- StabiLink®MIS Spinal Fixation System — Southern Spine LLC
- StabiLink®MIS Spinal Fixation System — Southern Spine LLC
- StabiLink®MIS Spinal Fixation System — Southern Spine 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Southern Spine LLC
Sources (1)
- FDA UDI c1b943af-9728-407b-97d1-da8c43e749be 35 fields · synced Jul 23, 2026