Stabilis
Stabilis NF Ti Cervical Interbody 14x12x11 10°, STERILE
7manufacturers in China registered for this device type
200catalogue numbers in this listing
1510(k) clearance
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 | Acuity Surgical Devices, LLC, 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 | Repacker / relabeller, Manufacturer |
| 510(k) | K230639 |
| Record published | 2024-07-06 |
| Record revised | 2025-07-14 (version 2) |
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 |
| Sizes | Height 5 to 15 mm; width 12 to 16 mm; angle 0 to 15 °; length 14 to 20 mm; length 14 to 20 µm; width 12 µm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30-14121110-SP | Length 14 mm | In distribution |
| 30-14120905-SP | Length 14 mm | In distribution |
| 30-18150915-SP | Length 18 mm | In distribution |
| 35-16141005 | Length 16 mm | In distribution |
| 35-20161200 | Length 20 mm | In distribution |
| 30-16140905-SP | Length 16 mm | In distribution |
| 35-14121015 | Length 14 mm | In distribution |
| 35-16140610 | Length 16 mm | In distribution |
| 35-20160610 | Length 20 mm | In distribution |
| 35-18151010 | Length 18 mm | In distribution |
| 35-16141100 | Length 16 mm | In distribution |
| 35-20160815 | Length 20 mm | In distribution |
| 30-18151110-SP | Length 18 mm | In distribution |
| 30-20160705-SP | Length 20 mm | In distribution |
| 30-16141115-SP | Length 16 mm | In distribution |
| 35-20160800 | Length 20 mm | In distribution |
| 30-18150710-SP | Length 18 mm | In distribution |
| 30-14121105-SP | Length 14 µm | In distribution |
| 35-14120705 | Length 14 mm | In distribution |
| 35-20160715 | Length 20 mm | In distribution |
| 35-14120505 | Length 14 mm | In distribution |
| 35-20161100 | Length 20 mm | In distribution |
| 35-20160710 | Length 20 mm | In distribution |
| 35-18150805 | Length 18 mm | In distribution |
| 30-18150905-SP | Width 15 mm | In distribution |
| 35-18151105 | Length 18 mm | In distribution |
| 35-14120805 | Length 14 mm | In distribution |
| 30-20160910-SP | Length 20 mm | In distribution |
| 35-14120605 | Length 14 mm | In distribution |
| 35-20160700 | Length 20 mm | In distribution |
| 30-18151010-SP | Length 18 mm | In distribution |
| 35-16141200 | Length 16 mm | In distribution |
| 30-14121215-SP | Length 14 mm | In distribution |
| 35-14121000 | Length 14 mm | In distribution |
| 35-14120500 | Length 14 mm | In distribution |
| 35-14121105 | Length 14 mm | In distribution |
| 30-18151015-SP | Length 18 mm | In distribution |
| 35-16141105 | Length 16 mm | In distribution |
| 35-18151210 | Length 18 mm | In distribution |
| 30-14120915-SP | Length 14 mm | In distribution |
| 30-18150505-SP | Length 18 mm | In distribution |
| 30-18150605-SP | Length 18 mm | In distribution |
| 35-16140815 | Length 16 mm | In distribution |
| 35-16140500 | Length 16 mm | In distribution |
| 30-14121205-SP | Length 14 mm | In distribution |
| 35-14120700 | Length 14 mm | In distribution |
| 35-20160705 | Length 20 mm | In distribution |
| 35-18150500 | Height 5 mm | In distribution |
| 35-14120900 | Length 14 mm | In distribution |
| 30-16141015-SP | Length 16 mm | In distribution |
| 35-14120815 | Length 14 mm | In distribution |
| 30-14120815-SP | Length 14 mm | In distribution |
| 30-20160915-SP | Length 20 mm | In distribution |
| 30-20160810-SP | Length 20 mm | In distribution |
| 35-14120600 | Length 14 mm | In distribution |
| 35-16140915 | Length 16 mm | In distribution |
| 35-18150905 | Length 18 mm | In distribution |
| 30-18151105-SP | Length 18 mm | In distribution |
| 30-20160605-SP | Length 20 mm | In distribution |
| 35-16141210 | Length 16 mm | In distribution |
| 30-20160610-SP | Length 20 mm | In distribution |
| 30-20161015-SP | Length 20 mm | In distribution |
| 35-20161000 | Length 20 mm | In distribution |
| 35-14121115 | Length 14 mm | In distribution |
| 35-20160500 | Length 20 mm | In distribution |
| 30-14121115-SP | Length 14 mm | In distribution |
| 30-16140710-SP | Length 16 mm | In distribution |
| 35-18150715 | Length 18 mm | In distribution |
| 35-20160900 | Length 20 mm | In distribution |
| 35-18150815 | Length 18 mm | In distribution |
| 30-20161105-SP | Length 20 mm | In distribution |
| 30-20160715-SP | Length 20 mm | In distribution |
| 30-18150705-SP | Length 18 mm | In distribution |
| 35-18150505 | Length 18 mm | In distribution |
| 35-18150610 | Length 18 mm | In distribution |
| 30-20160815-SP | Length 20 mm | In distribution |
| 35-18151100 | Length 18 mm | In distribution |
| 35-16140710 | Length 16 mm | In distribution |
| 35-16141115 | Length 16 mm | In distribution |
| 35-14121110 | Length 14 mm | In distribution |
| 30-18151215-SP | Length 18 mm | In distribution |
| 30-14120605-SP | Height 6 mm | In distribution |
| 30-20161010-SP | Length 20 mm | In distribution |
| 35-18150605 | Length 18 mm | In distribution |
| 35-18151005 | Length 18 mm | In distribution |
| 35-18151000 | Length 18 mm | In distribution |
| 35-20161005 | Length 20 mm | In distribution |
| 30-16141005-SP | Length 16 mm | In distribution |
| 35-20161205 | Length 20 mm | In distribution |
| 30-20160805-SP | Length 20 mm | In distribution |
| 35-20161215 | Length 20 mm | In distribution |
| 35-18150910 | Length 18 mm | In distribution |
| 35-14121005 | Length 14 mm | In distribution |
| 30-20160710-SP | Length 20 mm | In distribution |
| 30-16140505-SP | Length 16 mm | In distribution |
| 30-16141110-SP | Length 16 mm | In distribution |
| 35-20160605 | Length 20 mm | In distribution |
| 30-20160505-SP | Length 20 mm | In distribution |
| 30-20160905-SP | Length 20 µm | In distribution |
| 35-18151110 | Length 18 mm | In distribution |
| 30-14120805-SP | Length 14 mm | In distribution |
| 30-20161110-SP | Length 20 mm | In distribution |
| 35-18150800 | Length 18 mm | In distribution |
| 35-14121200 | Length 14 mm | In distribution |
| 35-16140800 | Length 16 mm | In distribution |
| 30-14120810-SP | Height 8 mm | In distribution |
| 30-18150910-SP | Length 18 mm | In distribution |
| 35-14120905 | Length 14 mm | In distribution |
| 30-20161215-SP | Length 20 mm | In distribution |
| 35-16141205 | Length 16 mm | In distribution |
| 35-14121210 | Length 14 mm | In distribution |
| 35-18150810 | Length 18 mm | In distribution |
| 35-18150600 | Length 18 mm | In distribution |
| 35-16140810 | Length 16 mm | In distribution |
| 35-18150700 | Length 18 mm | In distribution |
| 35-16140900 | Length 16 mm | In distribution |
| 30-16141210-SP | Length 16 mm | In distribution |
| 30-14121010-SP | Length 14 mm | In distribution |
| 30-16141010-SP | Length 16 mm | In distribution |
| 35-20160905 | Length 20 mm | In distribution |
| 35-14121010 | Length 14 mm | In distribution |
| 35-16141110 | Length 16 mm | In distribution |
| 35-18151015 | Length 18 mm | In distribution |
| 35-16140705 | Length 16 mm | In distribution |
| 35-18150710 | Length 18 mm | In distribution |
| 35-14120810 | Length 14 mm | In distribution |
| 35-20160910 | Length 20 mm | In distribution |
| 35-18151115 | Length 18 mm | In distribution |
| 30-18150805-SP | Length 18 mm | In distribution |
| 30-16140705-SP | Length 16 mm | In distribution |
| 35-18151215 | Length 18 mm | In distribution |
| 30-20161115-SP | Length 20 mm | In distribution |
| 35-14120715 | Length 14 mm | In distribution |
| 35-18151200 | Length 18 mm | In distribution |
| 35-16140805 | Length 16 mm | In distribution |
| 30-16141215-SP | Length 16 mm | In distribution |
| 30-18150815-SP | Length 18 mm | In distribution |
| 35-20161210 | Length 20 mm | In distribution |
| 30-14121210-SP | Length 14 mm | In distribution |
| 30-16140910-SP | Length 16 mm | In distribution |
| 35-20161115 | Length 20 mm | In distribution |
| 35-18151205 | Length 18 mm | In distribution |
| 30-14120505-SP | Height 5 mm | In distribution |
| 35-16140910 | Length 16 mm | In distribution |
| 30-16140715-SP | Length 16 mm | In distribution |
| 30-18151205-SP | Length 18 mm | In distribution |
| 35-20160600 | Length 20 mm | In distribution |
| 35-18150900 | Length 18 mm | In distribution |
| 30-18150715-SP | Length 18 mm | In distribution |
| 30-18150810-SP | Length 18 mm | In distribution |
| 30-14120705-SP | Height 7 mm | In distribution |
| 35-14120800 | Length 14 mm | In distribution |
| 30-18150610-SP | Length 18 mm | In distribution |
| 35-16140700 | Length 16 mm | In distribution |
| 35-20161105 | Length 20 mm | In distribution |
| 30-18151005-SP | Length 18 mm | In distribution |
| 35-16141015 | Length 16 mm | In distribution |
| 35-16140905 | Length 16 mm | In distribution |
| 30-16140805-SP | Length 16 mm | In distribution |
| 35-16141000 | Length 16 mm | In distribution |
| 35-16140505 | Length 16 mm | In distribution |
| 35-20160915 | Length 20 mm | In distribution |
| 30-16140605-SP | Length 16 mm | In distribution |
| 35-18150705 | Length 18 mm | In distribution |
| 35-14120915 | Length 14 mm | In distribution |
| 35-14120910 | Length 14 mm | In distribution |
| 30-14120710-SP | Height 7 mm | In distribution |
| 30-16140810-SP | Length 16 mm | In distribution |
| 35-20160505 | Length 20 mm | In distribution |
| 35-16140605 | Length 16 mm | In distribution |
| 35-16140715 | Length 16 mm | In distribution |
| 30-14121015-SP | Length 14 mm | In distribution |
| 35-14120610 | Length 14 mm | In distribution |
| 30-16141205-SP | Length 16 mm | In distribution |
| 35-16141010 | Length 16 mm | In distribution |
| 35-16141215 | Length 16 mm | In distribution |
| 35-18150915 | Length 18 mm | In distribution |
| 30-20161005-SP | Length 20 mm | In distribution |
| 30-16140610-SP | Length 16 mm | In distribution |
| 35-20161010 | Length 20 mm | In distribution |
| 30-18151210-SP | Length 18 mm | In distribution |
| 30-20161210-SP | Length 20 mm | In distribution |
| 35-14120710 | Length 14 mm | In distribution |
| 30-18151115-SP | Length 18 mm | In distribution |
| 35-20160810 | Length 20 mm | In distribution |
| 30-16140915-SP | Length 16 mm | In distribution |
| 30-14120910-SP | Length 14 mm | In distribution |
| 35-14121100 | Length 14 mm | In distribution |
| 35-16140600 | Length 16 mm | In distribution |
| 35-14121215 | Length 14 mm | In distribution |
| 30-14121005-SP | Length 14 mm | In distribution |
| 35-14121205 | Length 14 mm | In distribution |
| 35-20161110 | Length 20 mm | In distribution |
| 30-16140815-SP | Length 16 mm | In distribution |
| 35-20161015 | Length 20 mm | In distribution |
| 30-14120715-SP | Height 7 mm | In distribution |
| 35-20160805 | Length 20 mm | In distribution |
| 30-16141105-SP | Length 16 mm | In distribution |
| 30-20161205-SP | Length 20 mm | In distribution |
| 30-14120610-SP | Length 14 mm | 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 |
|---|---|
| K230639 | 2023-12-01 |
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.