Endoskeleton® TL Hyperlordotic
Endoskeleton TL Hyperlordotic is a lateral lumbar interbody fusion system with a titanium-alloy cage, integrated lateral plate and bone screws. The cage has a large central graft space and…
Endoskeleton TL Hyperlordotic is a lateral lumbar interbody fusion system with a titanium-alloy cage, integrated lateral plate and bone screws. The cage has a large central graft space and windows for viewing its position.
The implant uses nanoLOCK surface technology, creating microscopic roughness with nanoscale features. The lateral plate attaches to the cage and receives one or two screws, with a cover that resists screw back-out.
Listed Item
ENDOSKELETON® TLh Integrated Plate Inserter
Hyperlordotic Fixation
The hyperlordotic device is defined by an angle of at least 16 degrees. It requires the integrated lateral plate and bone screw plus additional posterior supplemental lumbar fixation. It is supplied sterile and used with the specified bone graft options for one or two adjacent levels from L2 to S1.
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Titan Spine, LLC, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K191581 |
| Record published | 2020-08-15 |
| Record revised | 2022-10-05 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2020-12-23 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7200-1090 | In distribution | |
| 7220-2516 | In distribution | |
| 7200-1091 | In distribution | |
| 7200-1088 | In distribution | |
| 7224-1519 | Withdrawn | |
| 7224-1520 | Withdrawn | |
| 7224-0518 | Withdrawn | |
| 7220-2515 | Withdrawn | |
| 7216-1519 | Withdrawn | |
| 7220-1517 | Withdrawn | |
| 7216-1516 | Withdrawn | |
| 7216-2513 | Withdrawn | |
| 7220-0515 | Withdrawn | |
| 7216-2517 | Withdrawn | |
| 7216-1512 | Withdrawn | |
| 7216-2514 | Withdrawn | |
| 7220-0518 | Withdrawn | |
| 7224-1518 | Withdrawn | |
| 7216-2512 | Withdrawn | |
| 7200-1120 | Withdrawn | |
| 7220-1519 | Withdrawn | |
| 7224-2519 | Withdrawn | |
| 7220-0519 | Withdrawn | |
| 7216-0520 | Withdrawn | |
| 7224-2517 | Withdrawn | |
| 7220-2520 | Withdrawn | |
| 7220-0514 | Withdrawn | |
| 7220-2514 | Withdrawn | |
| 7216-2518 | Withdrawn | |
| 7230-0516 | Withdrawn | |
| 7224-0513 | Withdrawn | |
| 7230-2518 | Withdrawn | |
| 7216-1518 | Withdrawn | |
| 7224-0517 | Withdrawn | |
| 7216-2515 | Withdrawn | |
| 7224-1516 | Withdrawn | |
| 7200-1106 | Withdrawn | |
| 7230-2520 | Withdrawn | |
| 7224-0519 | Withdrawn | |
| 7220-1515 | Withdrawn | |
| 7216-2519 | Withdrawn | |
| 7220-0520 | Withdrawn | |
| 7216-0515 | Withdrawn | |
| 7216-1517 | Withdrawn | |
| 7224-1515 | Withdrawn | |
| 7230-0520 | Withdrawn | |
| 7230-0517 | Withdrawn | |
| 7230-1517 | Withdrawn | |
| 7220-0517 | Withdrawn | |
| 7224-2520 | Withdrawn | |
| 7224-1514 | Withdrawn | |
| 7216-0519 | Withdrawn | |
| 7230-0514 | Withdrawn | |
| 7224-0520 | Withdrawn | |
| 7220-0513 | Withdrawn | |
| 7230-0515 | Withdrawn | |
| 7216-0509 | Withdrawn | |
| 7224-2516 | Withdrawn | |
| 7224-1517 | Withdrawn | |
| 7220-0516 | Withdrawn | |
| 7216-1514 | Withdrawn | |
| 7230-2519 | Withdrawn | |
| 7216-2520 | Withdrawn | |
| 7216-1515 | Withdrawn | |
| 7224-0512 | Withdrawn | |
| 7230-1519 | Withdrawn | |
| 7220-2519 | Withdrawn | |
| 7216-1510 | Withdrawn | |
| 7230-0518 | Withdrawn | |
| 7216-0517 | Withdrawn | |
| 7230-0519 | Withdrawn | |
| 7224-2518 | Withdrawn | |
| 7216-0511 | Withdrawn | |
| 7220-0511 | Withdrawn | |
| 7220-0512 | Withdrawn | |
| 7216-1513 | Withdrawn | |
| 7216-2516 | Withdrawn | |
| 7224-0515 | Withdrawn | |
| 7224-0514 | Withdrawn | |
| 7220-2518 | Withdrawn | |
| 7216-1520 | Withdrawn | |
| 7220-2517 | Withdrawn | |
| 7216-1511 | Withdrawn | |
| 7224-0516 | Withdrawn | |
| 7216-0513 | Withdrawn | |
| 7220-1513 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191581 | 2020-01-08 |
| K192054 | 2019-08-29 |
| K163269 | 2017-04-13 |
| K111626 | 2011-09-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.