Sage Cervical Interbody Fusion System
Sage Cervical Interbody Fusion System uses box-shaped spacers with a central graft chamber and teeth on the upper and lower surfaces. The chamber holds bone graft, while the teeth improve…
Sage Cervical Interbody Fusion System uses box-shaped spacers with a central graft chamber and teeth on the upper and lower surfaces. The chamber holds bone graft, while the teeth improve stability and help resist movement.
The range includes PEEK spacers with tantalum markers and titanium-alloy spacers. PEEK forms may have a commercially pure titanium plasma coating on the endplate-contacting surfaces.
Listed Item
PEEK Cervical Spacer with Titanium Plasma Coating, 16 x 13 x 10mm, 7 deg
Construct and Material Options
A listed coated PEEK cervical spacer is one configuration within the range. Footprint, style and size vary. The system is intended for one cervical level from C2 to T1 with autograft or specified allograft and supplemental cervical fixation.
7manufacturers in China registered for this device type
141catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 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 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Curiteva, Inc., United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K181261 |
| Record published | 2019-08-15 |
| Record revised | 2020-02-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Height 5 to 14 mm; depth 11 to 14 mm; width 12 to 18 mm; angle 7 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C214-141206-7 | Height 6 mm | In distribution |
| C224-161310-7CT | Angle 7 ° | In distribution |
| C224-161308-7CT | Angle 7 ° | In distribution |
| C204-141211-7 | Height 11 mm | In distribution |
| C224-121113-7CT | Height 13 mm | In distribution |
| C205-635 | Height 5 mm | In distribution |
| C214-161306-7 | Angle 7 ° | In distribution |
| C214-161309-7 | Height 9 mm | In distribution |
| C224-141210-7CT | Height 10 mm | In distribution |
| C214-181408-7 | Height 8 mm | In distribution |
| C214-121106-7 | Angle 7 ° | In distribution |
| C224-181406-7CT | Height 6 mm | In distribution |
| C224-141208-7CT | Height 8 mm | In distribution |
| C224-141209-7CT | Angle 7 ° | In distribution |
| C224-161307-7CT | Height 7 mm | In distribution |
| C214-181414-7 | Angle 7 ° | In distribution |
| C204-121107-7 | Angle 7 ° | In distribution |
| C205-627-STP | Height 9 mm | In distribution |
| C204-141209-7 | Height 9 mm | In distribution |
| C204-161305-7 | Height 5 mm | In distribution |
| C224-141206-7CT | Height 6 mm | In distribution |
| C205-618 | Height 11 mm | In distribution |
| C204-181410-7 | Angle 7 ° | In distribution |
| C224-141205-7CT | Angle 7 ° | In distribution |
| C214-181407-7 | Angle 7 ° | In distribution |
| C214-181410-7 | Height 10 mm | In distribution |
| C205-646-STP | Height 7 mm | In distribution |
| C214-141207-7 | Angle 7 ° | In distribution |
| C205-647 | Height 9 mm | In distribution |
| C204-181405-7 | Height 5 mm | In distribution |
| C205-617 | Height 9 mm | In distribution |
| C224-161312-7CT | Angle 7 ° | In distribution |
| C224-181411-7CT | Angle 7 ° | In distribution |
| C204-181412-7 | Angle 7 ° | In distribution |
| C214-161308-7 | Angle 7 ° | In distribution |
| C204-121109-7 | Angle 7 ° | In distribution |
| C205-628-STP | Height 11 mm | In distribution |
| C204-161312-7 | Angle 7 ° | In distribution |
| C214-121105-7 | Height 5 mm | In distribution |
| C205-635-STP | Height 5 mm | In distribution |
| C204-121110-7 | Height 10 mm | In distribution |
| C214-161305-7 | Height 5 mm | In distribution |
| C224-121114-7CT | Height 14 mm | In distribution |
| C214-181413-7 | Angle 7 ° | In distribution |
| C224-181410-7CT | Height 10 mm | In distribution |
| C224-121108-7CT | Angle 7 ° | In distribution |
| C205-627 | Height 9 mm | In distribution |
| C204-181409-7 | Height 9 mm | In distribution |
| C224-181405-7CT | Angle 7 ° | In distribution |
| C205-647-STP | Height 9 mm | In distribution |
| C214-181406-7 | Height 6 mm | In distribution |
| C224-121107-7CT | Height 7 mm | In distribution |
| C224-141207-7CT | Angle 7 ° | In distribution |
| C214-181409-7 | Angle 7 ° | In distribution |
| C205-637-STP | Height 9 mm | In distribution |
| C224-181413-7CT | Height 13 mm | In distribution |
| C214-141210-7 | Height 10 mm | In distribution |
| C204-161308-7 | Angle 7 ° | In distribution |
| C204-181406-7 | Angle 7 ° | In distribution |
| C214-121109-7 | Height 9 mm | In distribution |
| C204-161307-7 | Height 7 mm | In distribution |
| C214-161310-7 | Angle 7 ° | In distribution |
| C224-121111-7CT | Height 11 mm | In distribution |
| C204-121105-7 | Angle 7 ° | In distribution |
| C204-121108-7 | Height 8 mm | In distribution |
| C204-181407-7 | Height 7 mm | In distribution |
| C204-161311-7 | Height 11 mm | In distribution |
| C205-626-STP | Height 7 mm | In distribution |
| C205-310 | In distribution | |
| C214-181411-7 | Angle 7 ° | In distribution |
| C205-628 | Height 11 mm | In distribution |
| C205-626 | Height 7 mm | In distribution |
| C214-161311-7 | Height 11 mm | In distribution |
| C224-161306-7CT | Angle 7 ° | In distribution |
| C205-100 | In distribution | |
| C204-181408-7 | Angle 7 ° | In distribution |
| C205-500 | Height 5 mm | In distribution |
| C205-637 | Height 9 mm | In distribution |
| C214-141212-7 | Height 12 mm | In distribution |
| C205-300 | In distribution | |
| C214-121112-7 | Depth 11 mm | In distribution |
| C205-615 | Height 5 mm | In distribution |
| C214-121108-7 | Angle 7 ° | In distribution |
| C214-121107-7 | Height 7 mm | In distribution |
| C224-181407-7CT | Angle 7 ° | In distribution |
| C204-141210-7 | Angle 7 ° | In distribution |
| C205-200 | In distribution | |
| C214-181405-7 | Angle 7 ° | In distribution |
| C224-181409-7CT | Angle 7 ° | In distribution |
| C204-141212-7 | Angle 7 ° | In distribution |
| C205-645-STP | Height 5 mm | In distribution |
| C224-141214-7CT | Angle 7 ° | In distribution |
| C214-141208-7 | Height 8 mm | In distribution |
| C224-141211-7CT | Angle 7 ° | In distribution |
| C224-121109-7CT | Height 9 mm | In distribution |
| C224-121105-7CT | Height 5 mm | In distribution |
| C224-121106-7CT | Angle 7 ° | In distribution |
| C205-616 | Height 7 mm | In distribution |
| C214-161312-7 | Angle 7 ° | In distribution |
| C204-121111-7 | Angle 7 ° | In distribution |
| C214-141211-7 | Angle 7 ° | In distribution |
| C224-181414-7CT | Height 14 mm | In distribution |
| C224-141213-7CT | Angle 7 ° | In distribution |
| C204-181413-7 | Height 13 mm | In distribution |
| C204-121112-7 | Height 12 mm | In distribution |
| C205-636 | Height 7 mm | In distribution |
| C204-141206-7 | Angle 7 ° | In distribution |
| C224-181408-7CT | Height 8 mm | In distribution |
| C224-161309-7CT | Height 9 mm | In distribution |
| C205-636-STP | Height 7 mm | In distribution |
| C204-141208-7 | Angle 7 ° | In distribution |
| C205-625-STP | Height 5 mm | In distribution |
| C205-638 | Height 11 mm | In distribution |
| C205-638-STP | Height 11 mm | In distribution |
| C204-161306-7 | Angle 7 ° | In distribution |
| C214-141213-7 | Angle 7 ° | In distribution |
| C204-141207-7 | Height 7 mm | In distribution |
| C204-181411-7 | Height 11 mm | In distribution |
| C214-161307-7 | Height 7 mm | In distribution |
| C204-161310-7 | Angle 7 ° | In distribution |
| C204-121106-7 | Height 6 mm | In distribution |
| C204-141205-7 | Height 5 mm | In distribution |
| C224-121112-7CT | Angle 7 ° | In distribution |
| C205-648-STP | Height 11 mm | In distribution |
| C224-161305-7CT | Height 5 mm | In distribution |
| C204-181414-7 | Height 14 mm | In distribution |
| C204-161309-7 | Height 9 mm | In distribution |
| C214-181412-7 | Height 12 mm | In distribution |
| C224-141212-7CT | Height 12 mm | In distribution |
| C214-141205-7 | Angle 7 ° | In distribution |
| C205-625 | Height 5 mm | In distribution |
| C224-161311-7CT | Height 11 mm | In distribution |
| C214-141214-7 | Angle 7 ° | In distribution |
| C224-181412-7CT | Height 12 mm | In distribution |
| C205-646 | Height 7 mm | In distribution |
| C214-121111-7 | Width 12 mm | In distribution |
| C205-645 | Height 5 mm | In distribution |
| C214-121110-7 | Angle 7 ° | In distribution |
| C205-648 | Height 11 mm | In distribution |
| C224-121110-7CT | Angle 7 ° | In distribution |
| C214-141209-7 | Angle 7 ° | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252205 | 2026-01-16 |
| K254061 | 2026-01-15 |
| K213030 | 2023-02-13 |
| K181261 | 2018-07-09 |
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.