Scarlet AL-T Instrumentation
Lateral Implant Holder Small/Medium
3manufacturers in China registered for this device type
46catalogue 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 | 2020-01-29 |
| 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 | Height 10 to 25 mm; angle 10 to 30 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCA-TS 20 19-N | Height 19 mm | In distribution |
| SCA-IN 01 02-N | Height 15 mm | In distribution |
| SCA-TL 10 11-N | Angle 10 ° | In distribution |
| SCA-TS 10 18-N | Angle 10 ° | In distribution |
| SCA-TS 10 14-N | Angle 10 ° | In distribution |
| SCA-TM 10 13-N | Angle 10 ° | In distribution |
| SCA-TS 10 12-N | Angle 10 ° | In distribution |
| SCA-TL 20 19-N | Height 19 mm | In distribution |
| SCA-TS 30 19-N | Height 19 mm | In distribution |
| SCA-TM 20 14-N | Height 14 mm | In distribution |
| SCA-IN 03 03-N | Height 19 mm | In distribution |
| SCA-IN 04 02-N | Height 18 mm | In distribution |
| SCA-TS 15 16-N | Angle 15 ° | In distribution |
| SCA-IN 03 01-N | Height 15 mm | In distribution |
| SCA-TL 30 24-N | Height 24 mm | In distribution |
| SCA-TM 10 11-N | Angle 10 ° | In distribution |
| SCA-TL 30 20-N | Height 20 mm | In distribution |
| SCA-IN 01 04-N | Height 25 mm | In distribution |
| SCA-TL 15 12-N | Angle 15 ° | In distribution |
| SCA-TS 10 10-N | Angle 10 ° | In distribution |
| SCA-TL 10 13-N | Angle 10 ° | In distribution |
| SCA-TM 20 18-N | Height 18 mm | In distribution |
| SCA-TM 25 20-N | Height 20 mm | In distribution |
| SCA-TS 15 13-N | Angle 15 ° | In distribution |
| SCA-TL 10 16-N | Angle 10 ° | In distribution |
| SCA-TM 30 25-N | Height 25 mm | In distribution |
| SCA-TM 30 21-N | Height 21 mm | In distribution |
| SCA-IN 06 00-N | In distribution | |
| SCA-TS 15 11-N | Angle 15 ° | In distribution |
| SCA-TS 25 17-N | Height 17 mm | In distribution |
| SCA-TM 15 16-N | Angle 15 ° | In distribution |
| SCA-TL 15 18-N | Angle 15 ° | In distribution |
| SCA-TS 20 15-N | Height 15 mm | In distribution |
| SCA-IN 02 00-N | Height 12 mm | In distribution |
| SCA-TM 10 16-N | Angle 10 ° | In distribution |
| SCA-TM 15 13-N | Angle 15 ° | In distribution |
| SCA-IN 04 00-N | Height 12 mm | In distribution |
| SCA-TL 25 23-N | Height 23 mm | In distribution |
| SCA-TL 15 14-N | Angle 15 ° | In distribution |
| SCA-TM 15 11-N | Angle 15 ° | In distribution |
| SCA-TL 25 19-N | Height 19 mm | In distribution |
| SCA-TM 25 24-N | Height 24 mm | In distribution |
| SJT-IN 03 01-N | In distribution | |
| SCA-IN 02 02-N | Height 18 mm | In distribution |
| SCA-TS 25 21-N | Height 21 mm | In distribution |
| SCA-TL 20 15-N | Height 15 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 |
|---|---|
| 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.