Scarlet® AC-Ti
Secured Anterior Cervical Cage - Hyperlordotic
5manufacturers in China registered for this device type
72catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Spineart SA, Switzerland |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2024-08-05 |
| Record revised | 2025-07-14 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Depth 12 to 16 mm; width 15 to 18 mm; height 5 to 11 mm; angle 7 to 12 °; length 10 to 18 mm; outer diameter 3.2 to 3.7 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCA-TL LA 07-S | Depth 14 mm | In distribution |
| SCA-TA SM 10-S | Depth 12 mm | In distribution |
| SCA-TA LA 05-S | Depth 14 mm | In distribution |
| SCA-TS 37 12-S | Length 12 mm | In distribution |
| SCA-TA 37 12-S | Length 12 mm | In distribution |
| SCA-TA SM 05-S | Depth 12 mm | In distribution |
| SCA-TA XL 05-S | Depth 16 mm | In distribution |
| SCA-TH XL 10-S | Depth 16 mm | In distribution |
| SCA-TA SM 07-S | Depth 12 mm | In distribution |
| SCA-TL SM 08-S | Depth 12 mm | In distribution |
| SCA-TS 37 16-S | Length 16 mm | In distribution |
| SCA-TH XL 08-S | Depth 16 mm | In distribution |
| SCA-TH LA 09-S | Depth 14 mm | In distribution |
| SCA-TS 32 18-S | Length 18 mm | In distribution |
| SCA-TA SM 09-S | Depth 12 mm | In distribution |
| SCA-00 AX 05-N | Height 5 mm | In distribution |
| SCA-TH SM 11-S | Depth 12 mm | In distribution |
| SCA-IC 19 01-N | In distribution | |
| SCA-TH LA 08-S | Depth 14 mm | In distribution |
| SCA-TH XL 09-S | Depth 16 mm | In distribution |
| SCA-TS 32 14-S | Length 14 mm | In distribution |
| SCA-TA XL 09-S | Depth 16 mm | In distribution |
| SCA-TL LA 08-S | Depth 14 mm | In distribution |
| SCA-TH SM 10-S | Depth 12 mm | In distribution |
| SCA-TL XL 09-S | Depth 16 mm | In distribution |
| SCA-TH LA 06-S | Depth 14 mm | In distribution |
| SCA-TS 32 12-S | Length 12 mm | In distribution |
| SCA-TL SM 10-S | Depth 12 mm | In distribution |
| SCA-TA LA 09-S | Depth 14 mm | In distribution |
| SCA-TH LA 11-S | Depth 14 mm | In distribution |
| SCA-TS 32 16-S | Length 16 mm | In distribution |
| SCA-IC 19 04-N | In distribution | |
| SCA-TA LA 08-S | Depth 14 mm | In distribution |
| SCA-TH SM 08-S | Depth 12 mm | In distribution |
| SCA-00 AX 07-N | Depth 16 mm | In distribution |
| SCA-TH XL 11-S | Depth 16 mm | In distribution |
| SCA-TH SM 06-S | Depth 12 mm | In distribution |
| SCA-TA LA 10-S | Depth 14 mm | In distribution |
| SCA-TL XL 06-S | Depth 16 mm | In distribution |
| SCA-TS 37 14-S | Length 14 mm | In distribution |
| SCA-TH SM 07-S | Depth 12 mm | In distribution |
| SCA-IC 19 02-N | In distribution | |
| SCA-00 AX 08-N | Depth 16 mm | In distribution |
| SCA-TL LA 05-S | Depth 14 mm | In distribution |
| SCA-00 AX 06-N | Depth 16 mm | In distribution |
| SCA-TL SM 07-S | Depth 12 mm | In distribution |
| SCA-TS 37 18-S | Length 18 mm | In distribution |
| SCA-TL LA 06-S | Depth 14 mm | In distribution |
| SCA-TL XL 08-S | Depth 16 mm | In distribution |
| SCA-TA XL 06-S | Depth 16 mm | In distribution |
| SCA-TL XL 07-S | Depth 16 mm | In distribution |
| SCA-TH LA 10-S | Depth 14 mm | In distribution |
| SCA-TA SM 06-S | Depth 12 mm | In distribution |
| SCA-TH XL 07-S | Depth 16 mm | In distribution |
| SCA-TH XL 06-S | Depth 16 mm | In distribution |
| SCA-TA SM 08-S | Depth 12 mm | In distribution |
| SCA-TH SM 09-S | Depth 12 mm | In distribution |
| SCA-TL XL 05-S | Depth 16 mm | In distribution |
| SCA-TA XL 08-S | Depth 16 mm | In distribution |
| SCA-TL SM 06-S | Depth 12 mm | In distribution |
| SCA-TL SM 05-S | Depth 12 mm | In distribution |
| SCA-TA LA 06-S | Depth 14 mm | In distribution |
| SCA-TA XL 07-S | Depth 16 mm | In distribution |
| SCA-TA 37 14-S | Length 14 mm | In distribution |
| SCA-TL SM 09-S | Depth 12 mm | In distribution |
| SCA-TA XL 10-S | Depth 16 mm | In distribution |
| SCA-TA 37 10-S | Length 10 mm | In distribution |
| SCA-TA LA 07-S | Depth 14 mm | In distribution |
| SCA-TH LA 07-S | Depth 14 mm | In distribution |
| SCA-TL LA 09-S | Depth 14 mm | In distribution |
| SCA-TL LA 10-S | Depth 14 mm | In distribution |
| SCA-TL XL 10-S | Depth 16 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240699 | 2024-05-10 |
| K143214 | 2015-02-23 |
| K141314 | 2014-09-29 |
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.