Identity
- Trade Name
- T-LIFT® FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- T-LIFT, Straight, 25mm x 11mm FDA UDI
- Model / Reference
- 01-05000-11 FDA UDI
- Description
- T-LIFT, Straight, 25mm x 11mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190361002406 FDA UDI
- 510(k) Number
- K111553 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Polymeric 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
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
Dimensions & Sizes
- Size
- Length — 25 Millimeter FDA UDIHeight — 11 Millimeter FDA UDI
Category: Polymeric spinal interbody fusion cage
The T-LIFT Straight is a non-bioabsorbable synthetic polymer polymeric spinal interbody fusion cage device designed for the treatment of degenerative disc disease (DDD) by providing mechanical stability and sufficient space for therapeutic spinal bone fusion to occur.
Similar devices
Also classified as Polymeric spinal interbody fusion cage.
- L-Box® — Innovasis, Inc. · Class II
- CoRoent — Nuvasive, Inc. · Class II
- Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
- TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
- Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
Cleared under the same submission
K111553 also covers:
- A-LIFT® — SPINEFRONTIER, INC.
- A-LIFT® — SPINEFRONTIER, INC.
- A-LIFT® — SPINEFRONTIER, INC.
- A-LIFT® — SPINEFRONTIER, INC.
- A-LIFT® — SPINEFRONTIER, INC.
- Arena-L® — SPINEFRONTIER, INC.
- Arena-L® — SPINEFRONTIER, INC.
- Arena-L® — SPINEFRONTIER, INC.
- Arena-L® — SPINEFRONTIER, INC.
- Arena-L® — SPINEFRONTIER, INC.
- Arena-L® — SPINEFRONTIER, INC.
- Arena-L® — SPINEFRONTIER, INC.
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
- Spinefrontier, Inc.
Sources (1)
- FDA UDI efcf8c4d-5208-41b0-9694-29395dcf4f28 36 fields · synced Jul 24, 2026