Shoreline ACS
Shoreline ACS is a cervical fusion family containing implant assemblies, placement instruments, caddies and trays. Its implanted configuration combines a PEEK spacer with a titanium alloy…
Shoreline ACS is a cervical fusion family containing implant assemblies, placement instruments, caddies and trays. Its implanted configuration combines a PEEK spacer with a titanium alloy plate, bone screws and locking cover.
The spacer has a central graft canal and surface teeth. Low-profile and no-profile versions differ in their prominence in front of the disc space, with additional footprint, height and lordotic choices.
Listed Item
Modular Trial 16x14x11mm, 15 Deg Lordosis, w/ Depth Stop
Fixation and Surface Options
The locking cover physically blocks the screw heads against backout. Spacers are available with a commercially pure titanium NanoMetalene coating, and the no-profile design also has an uncoated option. Instruments and trials remain separate from the implanted assembly.
5manufacturers in China registered for this device type
428catalogue numbers in this listing
8510(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 | Seaspine Orthopedics Corporation, United States |
|---|---|
| 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 |
| 510(k) | K161081 |
| Record published | 2016-09-30 |
| Record revised | 2025-10-24 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2022-04-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 86-0908 | 20x15x8mm, 15 Degree | In distribution |
| 85-0212 | 16x14x12mm, 7 Degree | In distribution |
| 85-1007 | 18x15x7mm, 7 Degree | In distribution |
| 85-1106-S | 20x15x6mm, 7 Degree | In distribution |
| 85-1108 | 20x15x8mm, 7 Degree | In distribution |
| 85-1311 | 16x14x11mm, 10 Degree | In distribution |
| 85-1309 | 16x14x9mm, 10 Degree | In distribution |
| 85-3020 | 3.5mm, 20mm | In distribution |
| 85-0910 | 16x14x10mm, 7 Degree | In distribution |
| 85-4118 | 4.0mm, 18mm | In distribution |
| 86-1000 | In distribution | |
| 86-1010 | 10mm | In distribution |
| 85-0207 | 16x14x7mm, 7 Degree | In distribution |
| 86-9919 | 20x15mm | In distribution |
| 85-1008 | 18x15x8mm, 7 Degree | In distribution |
| 85-1812 | 18x15x12mm, 15 Degree | In distribution |
| 86-0112 | 14x13x12mm, 7 Degree | In distribution |
| 85-0812-S | In distribution | |
| 85-1912 | 20x15x12mm, 15 Degree | In distribution |
| 85-2006 | 6-7mm | In distribution |
| 86-0912 | 20x15x12mm, 15 Degree | In distribution |
| 85-1312-S | 16x14x12mm, 10 Degree | In distribution |
| 86-1511 | 20x15x11mm, 10 Deg | In distribution |
| 86-1510 | 20x15x10mm, 10 Deg | In distribution |
| 85-0308 | 18x15x8mm, 7 Degree | In distribution |
| 86-1411 | 18x15x11mm, 10 Deg | In distribution |
| 85-4018 | 4.0mm 18mm | In distribution |
| 86-0105 | 14x13x5mm, 7 Degree | In distribution |
| 86-2611 | 16x14x11mm, 15 Deg | In distribution |
| 86-9914 | In distribution | |
| 86-2409 | 20x15x9mm, 10 Deg | In distribution |
| 85-1911 | 20x15x11mm, 15 Degree | In distribution |
| 86-0609 | 18x15x9mm, 15 Degree | In distribution |
| 85-1010 | 18x15x10mm, 7 Degree | In distribution |
| 86-0511 | 16x14x11mm, 15 Degree | In distribution |
| 85-0910-S | 16x14x10mm, 7 Degree | In distribution |
| 86-2212 | 16x14x12mm, 10 Deg | In distribution |
| 85-1508 | 20x15x8mm, 10 Degree | In distribution |
| 86-0107 | 14x13x7mm, 7 Degree | In distribution |
| 85-0212-S | 16x14x12mm, 7 Degree | In distribution |
| 86-2207 | 16x14x7mm, 10 Deg | In distribution |
| 85-1908-S | 20x15x8mm, 15 Degree | In distribution |
| 86-2310 | 18x15x10mm, 10 Deg | In distribution |
| 85-1708-S | 18x15x8mm, 15 Degree | In distribution |
| 86-0210 | 16x14x10mm, 7 Degree | In distribution |
| 86-0013 | In distribution | |
| 86-0310 | 18x15x10mm, 7 Degree | In distribution |
| 85-2309 | 9mm | In distribution |
| 85-1109 | 20x15x9mm, 7 Degree | In distribution |
| 85-4316 | 4.0mm, 16mm | In distribution |
| 85-2312 | 12mm | In distribution |
| 86-9903 | In distribution | |
| 85-0708 | 8mm | In distribution |
| 86-9915 | 3.5mm | In distribution |
| 85-0309-S | 18x15x9mm, 7 Degree | In distribution |
| 85-1909-S | 20x15x9mm, 15 Degree | In distribution |
| 86-1212 | 14x13x12mm, 10 Deg | In distribution |
| 86-1310 | 16x14x10mm, 10 Deg | In distribution |
| 85-1109-S | 20x15x9mm, 7 Degree | In distribution |
| 86-1406 | 18x15x6mm, 10 Deg | In distribution |
| 85-0905-S | 16x14x5mm, 7 Degree | In distribution |
| 85-0512 | 12mm | In distribution |
| 85-0706 | 6mm | In distribution |
| 85-1506-S | 20x15x6mm, 10 Degree | In distribution |
| 86-1011 | 11mm | In distribution |
| 86-1407 | 18x15x7mm, 10 Deg | In distribution |
| 85-1507-S | 20x15x7mm, 10 Degree | In distribution |
| 85-1010-S | 18x15x10mm, 7 Degree | In distribution |
| 85-0806-S | In distribution | |
| 85-1509 | 20x15x9mm, 10 Degree | In distribution |
| 85-1912-S | 20x15x12mm, 15 Degree | In distribution |
| 85-1611-S | 16x14x11mm, 15 Degree | In distribution |
| 86-2809 | 20x15x9mm, 15 Deg | In distribution |
| 85-2111 | 11mm | In distribution |
| 86-0909 | 20x15x9mm, 15 Degree | In distribution |
| 85-0607 | 7mm | In distribution |
| 86-9917 | In distribution | |
| 85-0406-S | In distribution | |
| 85-1812-S | 20x15x12mm, 15 Degree | In distribution |
| 85-0811 | 14x13x11mm, 7 Degree | In distribution |
| 85-0809 | 14x13x9mm, 7 Degree | In distribution |
| 85-1310 | 16x14x10mm, 10 Degree | In distribution |
| 85-0110 | 14x13x10mm, 7 Degree | In distribution |
| 85-1411 | 18x15x11mm, 10 Degree | In distribution |
| 85-0510 | 10mm | In distribution |
| 85-0409-S | In distribution | |
| 86-0309 | 18x15x9mm, 7 Degree | In distribution |
| 85-1107 | 20x15x7mm, 7 Degree | In distribution |
| 86-1311 | 16x14x11mm, 10 Deg | In distribution |
| 85-3214 | 3.5mm 14mm | In distribution |
| 86-1009 | 9mm | In distribution |
| 86-0209 | 16x14x9mm, 7 Degree | In distribution |
| 85-1410 | 18x15x10mm, 10 Degree | In distribution |
| 85-1005 | 18x15x5mm, 7 Degree | In distribution |
| 86-2610 | 16x14x10mm, 15 Deg | In distribution |
| 85-2311 | 11mm | In distribution |
| 85-3016 | 3.5mm 16mm | In distribution |
| 85-1412-S | 18x15x12mm, 10 Degree | In distribution |
| 85-1908 | 20x15x8mm, 15 Degree | In distribution |
| 85-0208-S | 16x14x8mm, 7 Degree | In distribution |
| 85-1006 | 18x15x6mm, 7 Degree | In distribution |
| 86-0207 | 16x14x7mm, 7 Degree | In distribution |
| 86-0206 | 16x14x6mm, 7 Degree | In distribution |
| 85-1212-S | In distribution | |
| 85-0812 | 14x13x12mm, 7 Degree | In distribution |
| 85-0809-S | In distribution | |
| 86-0401-10 | In distribution | |
| 85-0309 | 18x15x9mm, 7 Degree | In distribution |
| 86-1412 | 18x15x12mm, 10 Deg | In distribution |
| 85-1909 | 20x15x9mm, 15 Degree | In distribution |
| 86-1210 | 14x13x10mm, 10 Deg | In distribution |
| 86-0407 | 20x15x7mm, 7 Deg | In distribution |
| 85-0407-S | In distribution | |
| 86-0405 | 14x13x5mm | In distribution |
| 86-0311 | 18x15x11mm, 7 Degree | In distribution |
| 86-9911 | In distribution | |
| 85-1710 | 16x14x10mm, 15 Degree | In distribution |
| 85-2110 | 10mm | In distribution |
| 85-0807 | 14x13x7mm, 7 Degree | In distribution |
| 85-0711 | 11mm | In distribution |
| 85-0509 | 9mm | In distribution |
| 86-2810 | 20x15x10mm, 15 Deg | In distribution |
| 85-1009 | 18x15x9mm, 7 Degree | In distribution |
| 85-0712 | 12mm | In distribution |
| 86-0507 | 16x14x7mm, 15 Degree | In distribution |
| 86-0111 | 14x13x11mm, 7 Degree | In distribution |
| 86-9901 | In distribution | |
| 86-2308 | 18x15x8mm, 10 Deg | In distribution |
| 85-1709 | 16x14x9mm, 15 Degree | In distribution |
| 85-0611 | 11mm | In distribution |
| 85-1409 | 18x15x9mm, 10 Degree | In distribution |
| 85-1508-S | 20x15x8mm, 10 Degree | In distribution |
| 86-9902 | In distribution | |
| 86-0608 | 18x15x8mm, 15 Degree | In distribution |
| 85-0109-S | In distribution | |
| 86-1506 | 20x15x6mm, 10 Deg | In distribution |
| 85-0909 | 16x14x9mm, 7 Degree | In distribution |
| 86-1012 | 12mm | In distribution |
| 85-0108-S | In distribution | |
| 85-1105 | 20x15x5mm, 7 Degree | In distribution |
| 86-0306 | 18x15x6mm, 7 Degree | In distribution |
| 85-0410-S | In distribution | |
| 85-2307 | 7mm | In distribution |
| 85-0310-S | 18x15x10mm, 7 Degree | In distribution |
| 85-1910-S | 20x15x10mm, 15 Degree | In distribution |
| 85-1207-S | In distribution | |
| 85-0108 | 14x13x8mm, 7 Degree | In distribution |
| 86-1008 | 8mm | In distribution |
| 85-1209-S | In distribution | |
| 85-0912 | 16x14x12mm, 7 Degree | In distribution |
| 85-0810-S | In distribution | |
| 86-0205 | 16x14x5mm, 7 Degree | In distribution |
| 85-0109 | 14x13x9mm, 7 Degree | In distribution |
| 85-1612-S | 16x14x12mm, 15 Degree | In distribution |
| 85-1811 | 18x15x11mm, 15 Degree | In distribution |
| 86-2307 | 18x15x7mm, 10 Deg | In distribution |
| 85-3320 | 3.5mm, 20mm | In distribution |
| 86-2708 | 18x15x8mm, 15 Deg | In distribution |
| 85-1808-S | 20x15x8mm, 15 Degree | In distribution |
| 85-0310 | 18x15x10mm, 7 Degree | In distribution |
| 86-1211 | 14x13x11mm, 10 Deg | In distribution |
| 85-0209-S | 16x14x9mm, 7 Degree | In distribution |
| 85-0606 | 6mm | In distribution |
| 85-1309-S | 16x14x9mm, 10 Degree | In distribution |
| 85-1409-S | 18x15x9mm, 10 Degree | In distribution |
| 85-0206-S | 16x14x6mm, 7 Degree | In distribution |
| 85-0807-S | In distribution | |
| 85-0312-S | 18x15x12mm, 7 Degree | In distribution |
| 85-0905 | 16x14x5mm, 7 Degree | In distribution |
| 86-2412 | 20x15x12mm, 10 Deg | In distribution |
| 86-0211 | 16x14x11mm, 7 Degree | In distribution |
| 86-0409 | 20x15x9mm, 7 Deg | In distribution |
| 85-1411-S | 18x15x11mm, 10 Degree | In distribution |
| 86-0610 | 18x15x10mm, 15 Degree | In distribution |
| 85-2108 | 8mm | In distribution |
| 86-2209 | 16x14x9mm, 10 Deg | In distribution |
| 85-1112 | 20x15x12mm, 7 Degree | In distribution |
| 85-4020 | 4.0mm, 20mm | In distribution |
| 85-1707-S | 16x14x7mm, 15 Degree | In distribution |
| 86-2208 | 16x14x8mm, 10 Deg | In distribution |
| 85-0907 | 16x14x7mm, 7 Degree | In distribution |
| 85-0308-S | 18x15x8mm, 7 Degree | In distribution |
| 85-1012 | 18x15x12mm, 7 Degree | In distribution |
| 85-0707 | 7mm | In distribution |
| 85-0307 | 18x15x7mm, 7 Degree | In distribution |
| 86-1208 | 14x13x8mm, 10 Deg | In distribution |
| 85-1608-S | 16x14x8mm, 15 Degree | In distribution |
| 85-0111 | 14x13x11mm, 7 Degree | In distribution |
| 85-1308 | 16x14x8mm, 10 Degree | In distribution |
| 85-1108-S | 20x15x8mm, 7 Degree | In distribution |
| 86-1006 | 6mm | In distribution |
| 85-1107-S | 20x15x7mm, 7 Degree | In distribution |
| 85-1306-S | 16x14x6mm, 10 Degree | In distribution |
| 86-0510 | 16x14x10mm, 15 Degree | In distribution |
| 85-0311-S | 18x15x11mm, 7 Degree | In distribution |
| 85-1911-S | 20x15x11mm, 15 Degree | In distribution |
| 85-0810 | 14x13x10mm, 7 Degree | In distribution |
| 85-4012 | 4.0mm 12mm | In distribution |
| 85-0912-S | 16x14x12mm, 7 Degree | In distribution |
| 85-2107 | 7mm | In distribution |
| 85-0307-S | 18x15x7mm, 7 Degree | In distribution |
| 85-0206 | 16x14x6mm, 7 Degree | In distribution |
| 85-0610 | 10mm | In distribution |
| 86-0401 | In distribution | |
| 85-2109 | 9mm | In distribution |
| 85-3218 | 3.5mm 18mm | In distribution |
| 85-4212 | 4.0mm 12mm | In distribution |
| 85-0508 | 8mm | In distribution |
| 85-3120 | 3.5mm, 20mm | In distribution |
| 85-0107-S | In distribution | |
| 85-1610-S | 16x14x10mm, 15 Degree | In distribution |
| 85-3318 | 3.5mm, 18mm | In distribution |
| 85-1009-S | 18x15x9mm, 7 Degree | In distribution |
| 86-9913 | In distribution | |
| 86-0412 | 20x15x12mm, 7 Deg | In distribution |
| 85-1307 | 16x14x7mm, 10 Degree | In distribution |
| 85-1910 | 20x15x10mm, 15 Degree | In distribution |
| 85-3314 | 3.5mm, 14mm | In distribution |
| 85-2305 | 5mm | In distribution |
| 85-0211-S | 16x14x11mm, 7 Degree | In distribution |
| 86-2808 | 20x15x8mm, 15 Deg | In distribution |
| 85-1510-S | 20x15x10mm, 10 Degree | In distribution |
| 85-1211-S | In distribution | |
| 85-1609-S | 16x14x9mm, 15 Degree | In distribution |
| 86-9912 | In distribution | |
| 85-0207-S | 16x14x7mm, 7 Degree | In distribution |
| 85-0408-S | In distribution | |
| 85-4014 | 4.0mm 14mm | In distribution |
| 85-1112-S | 20x15x12mm, 7 Degree | In distribution |
| 85-1407 | 18x15x7mm, 10 Degree | In distribution |
| 85-1707 | 16x14x7mm, 15 Degree | In distribution |
| 86-1206 | 14x13x6mm, 10 Deg | In distribution |
| 85-1006-S | 18x15x6mm, 7 Degree | In distribution |
| 85-4216 | 4.0mm 16mm | In distribution |
| 85-1111-S | 20x15x11mm, 7 Degree | In distribution |
| 85-1008-S | 18x15x8mm, 7 Degree | In distribution |
| 85-1011 | 18x15x11mm, 7 Degree | In distribution |
| 85-0911-S | 16x14x11mm, 7 Degree | In distribution |
| 86-0911 | 20x15x11mm, 15 Degree | In distribution |
| 86-9905 | In distribution | |
| 86-0512 | 16x14x12mm, 15 Degree | In distribution |
| 86-1507 | 20x15x7mm, 10 Deg | In distribution |
| 86-2309 | 18x15x9mm, 10 Deg | In distribution |
| 85-4114 | 4.0mm, 14mm | In distribution |
| 85-1308-S | 16x14x8mm, 10 Degree | In distribution |
| 85-1410-S | 18x15x10mm, 10 Degree | In distribution |
| 85-0808-S | In distribution | |
| 86-2312 | 18x15x12mm, 10 Deg | In distribution |
| 86-2211 | 16x14x11mm, 10 Deg | In distribution |
| 85-2112 | 12mm | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| A-Cift | Spinefrontier, Inc. | 254 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233414 | 2023-11-28 |
| K212904 | 2021-12-14 |
| K213359 | 2021-12-09 |
| K201073 | 2020-09-18 |
| K201646 | 2020-09-14 |
| K190655 | 2019-04-29 |
| K170569 | 2017-06-15 |
| K161081 | 2016-09-14 |
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.