Scarlet® AL-T Intervertebral Body Fusion Device
44 catalogue numbers from SCA-LS 20 15-S, listed by Spineart SA, Switzerland, under Intervertebral Fusion Device With Bone Graft, Lumbar. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
44catalogue numbers in this listing
12510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Spineart SA, Switzerland |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, 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 10) |
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 | Angle 10 to 30 °; height 10 to 26 mm; outer diameter 5 to 5.5 mm; length 30 to 60 mm |
| Distribution end date | 2018-12-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCA-LS 20 15-S | Angle 20 ° | In distribution |
| SCA-LM 10 14-S | Height 14 mm | In distribution |
| SCA-LS 15 14-S | Height 14 mm | In distribution |
| SCA-LM 25 20-S | Angle 25 ° | In distribution |
| SCA-LL 10 18-S | Height 18 mm | In distribution |
| SCA-LS 10 11-S | Height 11 mm | In distribution |
| SCA-LS 15 12-S | Height 12 mm | In distribution |
| SCA-LM 10 10-S | Height 10 mm | In distribution |
| SCA-LL 20 17-S | Angle 20 ° | In distribution |
| SCA-LM 20 20-S | Angle 20 ° | In distribution |
| SCA-LM 10 12-S | Height 12 mm | In distribution |
| SJT-LS 55 30-S | Outer Diameter 5.5 mm | In distribution |
| SCA-LM 20 16-S | Angle 20 ° | In distribution |
| SJT-LS 55 40-S | Outer Diameter 5.5 mm | In distribution |
| SCA-LM 10 18-S | Height 18 mm | In distribution |
| SCA-LS 25 17-S | Angle 25 ° | In distribution |
| SJT-LS 50 40-S | Outer Diameter 5 mm | In distribution |
| SCA-LS 20 19-S | Angle 20 ° | In distribution |
| SCA-LS 15 18-S | Height 18 mm | In distribution |
| SCA-LM 15 14-S | Height 14 mm | In distribution |
| SCA-LL 10 10-S | Height 10 mm | In distribution |
| SCA-LM 30 25-S | Angle 30 ° | In distribution |
| SCA-LL 25 25-S | Angle 25 ° | In distribution |
| SCA-LL 15 16-S | Height 16 mm | In distribution |
| SCA-LL 30 26-S | Angle 30 ° | In distribution |
| SCA-LS 10 16-S | Height 16 mm | In distribution |
| SCA-LM 15 18-S | Height 18 mm | In distribution |
| SCA-LM 25 24-S | Angle 25 ° | In distribution |
| SCA-LL 15 13-S | Height 13 mm | In distribution |
| SCA-LL 20 21-S | Angle 20 ° | In distribution |
| SCA-LM 15 12-S | Height 12 mm | In distribution |
| SJT-LS 50 30-S | Outer Diameter 5 mm | In distribution |
| SCA-LL 30 22-S | Angle 30 ° | In distribution |
| SCA-LL 25 21-S | Angle 25 ° | In distribution |
| SCA-LS 10 13-S | Height 13 mm | In distribution |
| SCA-LS 25 21-S | Angle 25 ° | In distribution |
| SCA-LS 15 10-S | Height 10 mm | In distribution |
| SCA-LL 10 14-S | Height 14 mm | In distribution |
| SCA-LM 30 21-S | Angle 30 ° | In distribution |
| SCA-LS 30 19-S | Angle 30 ° | In distribution |
| SJT-LS 55 50-S | Outer Diameter 5.5 mm | Withdrawn |
| SJT-LS 55 60-S | Outer Diameter 5.5 mm | Withdrawn |
| SJT-LS 50 60-S | Outer Diameter 5 mm | Withdrawn |
| SJT-LS 50 50-S | Outer Diameter 5 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261049 | 2026-08-20 |
| K242589 | 2024-10-23 |
| K181203 | 2018-06-28 |
| K173702 | 2018-01-03 |
| K161888 | 2016-09-12 |
| K153621 | 2016-07-15 |
| K141135 | 2014-12-01 |
| K142277 | 2014-10-14 |
| K140474 | 2014-04-18 |
| K133557 | 2014-02-03 |
| K101720 | 2010-07-16 |
| K081888 | 2009-02-06 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-02-05 | Class III | Employee error | Inner blister pack label is incorrect and does not match the correct external box label. | 14 pieces distribtued to 1 US Distributor | 2021-04-28 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
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.