Identity
- Trade Name
- MIDLINE II-Ti FDA UDI
- Generic Name
- Metal-polymer composite spinal interbody fusion cage FDA UDI
- Model / Reference
- M421516c FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815101021928 FDA UDI
- 510(k) Number
- K141942 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Metal-polymer composite spinal interbody fusion cage 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Metal-polymer composite spinal interbody fusion cage
MIDLINE II-Ti by Centinel Spine, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metal-polymer composite spinal interbody fusion cage.
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- Irix-A Lumbar Integrated Fusion System — Xtant Medical Holdings, Inc. · Class II
- Tyber Medical — Tyber Medical · Class II
- Reef TA — SeaSpine Orthopedics Corporation · Class II
- ROI-C — Ldr Spine USA · Class II
- LUCENT XP ARC — SPINAL ELEMENTS, INC. · Class II
- Shoreline ACS — SeaSpine Orthopedics Corporation · Class II
- Latitude-C Cervical Interbody Spacer System — Degen Medical · Class II
Cleared under the same submission
K141942 also covers:
- MIDLINE II-Ti — Centinel Spine, LLC
- MIDLINE II-Ti — Centinel Spine, LLC
- MIDLINE II-Ti — Centinel Spine, LLC
- MIDLINE II-Ti — Centinel Spine, LLC
- MIDLINE II-Ti — Centinel Spine, LLC
- MIDLINE II-Ti — Centinel Spine, LLC
- MIDLINE II-Ti — Centinel Spine, LLC
- MIDLINE II-Ti — Centinel Spine, LLC
- MIDLINE II-Ti — Centinel Spine, LLC
- MIDLINE II-Ti — Centinel Spine, LLC
- MIDLINE II-Ti — Centinel Spine, LLC
- MIDLINE II-Ti — Centinel 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 |
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Manufacturer
- Manufacturer
- Centinel Spine, LLC
Sources (1)
- FDA UDI 6fe64c28-2f67-40d6-b352-2f34f426b703 33 fields · synced Jun 1, 2026