Juliet ® Ti LL Instrumentation
Angled Trial 21mm H08 Lordosis 8°
3manufacturers in China registered for this device type
20catalogue numbers in this listing
4510(k) clearances naming this product code
1recall
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 | Spineart SA, Switzerland |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2019-06-06 |
| Record revised | 2025-03-31 (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 |
| Sizes | Length 17 to 21 mm; angle 8 to 25 °; height 8 to 18 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| JLL-IN 29 08-N | Length 21 mm | In distribution |
| JLL-IN 28 08-N | Length 21 mm | In distribution |
| JLL-IN 16 12-N | Height 12 mm | In distribution |
| JLL-IN 28 12-N | Length 21 mm | In distribution |
| JLL-IN 25 18-N | Angle 25 ° | In distribution |
| JLL-IN 29 12-N | Length 21 mm | In distribution |
| JLL-IN 19 12-N | Length 17 mm | In distribution |
| JLL-IN 44 00-N | In distribution | |
| JLL-IN 18 12-N | Length 17 mm | In distribution |
| JLL-IN 38 00-N | In distribution | |
| JLL-IN 45 00-N | In distribution | |
| JLL-IN 26 16-N | Height 16 mm | In distribution |
| JLL-IN 43 01-N | In distribution | |
| JLL-IN 18 08-N | Length 17 mm | In distribution |
| JLL-IN 19 08-N | Length 17 mm | In distribution |
| JLL-IN 16 16-N | Height 16 mm | In distribution |
| JLL-IN 42 00-N | In distribution | |
| JLL-IN 40 00-N | In distribution | |
| JLL-IN 15 14-N | Angle 15 ° | In distribution |
| JLL-IN 25 14-N | Angle 25 ° | 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 |
|---|---|
| K241321 | 2024-07-18 |
| K192993 | 2020-01-22 |
| K190877 | 2019-05-29 |
| K181818 | 2018-10-09 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-03-16 | Class II | Process change control | JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the preparation stage before implantation, or during surgery when removing the implant holder, which could cause surgical delay. | 544 |
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.