Endoskeleton® TL Hyperlordotic Sterile Barrier System
The Endoskeleton TL Hyperlordotic Lateral Plate stabilizes a compatible lumbar interbody fusion device. The plate attaches to the spacer and accepts integrated bone screws, with a lock…
The Endoskeleton TL Hyperlordotic Lateral Plate stabilizes a compatible lumbar interbody fusion device. The plate attaches to the spacer and accepts integrated bone screws, with a lock cover designed to resist screw backout.
The plate family includes one-hole and two-hole configurations for the associated interbody system. Implant components are made from Ti-6Al-4V ELI titanium alloy and are supplied sterile.
Listed Item
Lateral Plate, 1 Screw Hole, 14mm
Fusion Setup
The system is used for lateral lumbar fusion in skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2 to S1 after six months of nonoperative treatment. The spacer requires appropriate bone graft, its integrated lateral plate and screw, and posterior supplemental spinal fixation.
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 | 2024-09-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 5.5 to 6.5 mm; length 25 to 60 mm; height 14 to 18 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7300-6525-S | Outer Diameter 6.5 mm | In distribution |
| 7300-6550-S | Length 50 mm | In distribution |
| 7300-6535-S | Outer Diameter 6.5 mm | In distribution |
| 7300-0114-S | 1 Screw Hole, 14mm | In distribution |
| 7300-0218-S | 2 Screw Hole, 18mm | In distribution |
| 7300-6555-S | Outer Diameter 6.5 mm | In distribution |
| 7300-5540-S | 5.5mm Diameter, 40mm Length | In distribution |
| 7300-6560-S | Outer Diameter 6.5 mm | In distribution |
| 7300-5560-S | Bome Screw | In distribution |
| 7300-5555-S | 5.5mm Diameter, 55mm Length | In distribution |
| 7300-6545-S | Bome Screw | In distribution |
| 7300-6530-S | Outer Diameter 6.5 mm | In distribution |
| 7300-6540-S | Outer Diameter 6.5 mm | In distribution |
| 7300-5550-S | 5.5mm Diameter, 50mm Length | In distribution |
| 7300-0118-S | Height 18 mm | In distribution |
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.