Identity
- Trade Name
- Fortilink Cages with TiPlus Technology FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Model / Reference
- Fortilink®-C FDA UDI
Identifiers
- Catalog Number
- 67-C-1210-08-10L FDA UDI
- Primary DI / UDI-DI
- 08720246784541 FDA UDI
- 510(k) Number
- K201453 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Metallic 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
No
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: Metallic spinal interbody fusion cage
Discover the latest innovation in spinal fusion technology with Fortilink Cages with TiPlus Technology. This patented metallic spinal interbody fusion cage provides mechanical stability and sufficient space for therapeutic bone fusion to occur, making it an ideal solution for treating degenerative disc disease (DDD).
Similar devices
Also classified as Metallic spinal interbody fusion cage.
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- Peridot-PT Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
- CoRoent — Nuvasive, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- MectaLIF 3D — Medacta International · Class II
- PILLAR TL — Orthofix US LLC · Class II
- Solar™ Interbody Fusion System — Degen Medical · Class II
- Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
Cleared under the same submission
K201453 also covers:
- Fortilink Cages with TiPlus Technology — Baat Medical Products B.V.
- Fortilink Cages with TiPlus Technology — Baat Medical Products B.V.
- Fortilink Cages with TiPlus Technology — Baat Medical Products B.V.
- Fortilink Cages with TiPlus Technology — Baat Medical Products B.V.
- Fortilink Cages with TiPlus Technology — Baat Medical Products B.V.
- Fortilink Cages with TiPlus Technology — Baat Medical Products B.V.
- Fortilink Cages with TiPlus Technology — Baat Medical Products B.V.
- Fortilink Cages with TiPlus Technology — Baat Medical Products B.V.
- Fortilink Cages with TiPlus Technology — Baat Medical Products B.V.
- Fortilink Cages with TiPlus Technology — Baat Medical Products B.V.
- Fortilink Cages with TiPlus Technology — Baat Medical Products B.V.
- Fortilink Cages with TiPlus Technology — Baat Medical Products B.V.
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
- Baat Medical Products B.V.
Sources (1)
- FDA UDI 09f70df0-8fb6-437b-b652-3badfb78c647 34 fields · synced Oct 7, 2026