Divergence™ Anterior Cervical Fusion System
Implant G7736520 MP Lordo 10MMX15MMX12MM
7manufacturers in China registered for this device type
143catalogue numbers in this listing
2510(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 | Medtronic Sofamor Danek, 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 |
| 510(k) | K142450 |
| Record published | 2015-08-18 |
| Record revised | 2024-09-11 (version 9) |
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 |
| Sizes | Height 5 to 12 mm; length 9 to 24 mm; width 15 to 20 mm; angle 0 to 6 °; depth 9.4 to 13.4 mm; outer diameter 3.5 to 4 mm |
| Distribution end date | 2025-12-11 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 77365256 | 6DEG 5-6mm x 15mm x 12mm | In distribution | |
| G7743513 | Length 13.0 mm | 2 | In distribution |
| G7731506 | In distribution | ||
| 77307478 | 0DEG 7-8mm x 17mm x 14mm | In distribution | |
| 77367456 | In distribution | ||
| G7733511 | Outer Diameter 3.5 mm | 2 | In distribution |
| 77305256 | In distribution | ||
| G7731505 | In distribution | ||
| 7730805 | Height 5.0 mm | In distribution | |
| G7736525 | Depth 9.4 mm | In distribution | |
| G7744015 | Outer Diameter 4.0 mm | In distribution | |
| 77362490 | 6DEG 9-10mm x 20mm x 14mm | In distribution | |
| G7730527 | Angle 0.0 ° | In distribution | |
| G7731506 | Length 16.5 mm | In distribution | |
| G7734015 | Outer Diameter 4.0 mm | In distribution | |
| G7736529 | Depth 9.4 mm | In distribution | |
| G7736746 | In distribution | ||
| G7734011 | Length 11.0 mm | In distribution | |
| 7730809 | Height 9.0 mm | In distribution | |
| G7733515 | Outer Diameter 3.5 mm | 2 | In distribution |
| G7733515 | 2 | In distribution | |
| G7734015 | In distribution | ||
| 77367478 | 6DEG 7-8mm x 17mm x 14mm | In distribution | |
| G7731510 | Length 20.5 mm | In distribution | |
| G7736745 | Height 5.0 mm | In distribution | |
| 77305256 | 0DEG 5-6mm x 15mm x 12mm | In distribution | |
| 7730815 | In distribution | ||
| 7730816 | In distribution | ||
| 77305290 | 0DEG 9-10mm x 15mm x 12mm | In distribution | |
| 77365278 | In distribution | ||
| 77307478 | In distribution | ||
| G7731509 | Length 19.5 mm | In distribution | |
| G7736746 | Depth 11.4 mm | In distribution | |
| G7736529 | In distribution | ||
| G7730747 | Width 17.0 mm | In distribution | |
| G7734013 | Outer Diameter 4.0 mm | In distribution | |
| G7730746 | Depth 11.4 mm | In distribution | |
| G7744011 | Length 11.0 mm | In distribution | |
| 77365290 | 0DEG 9-10mm x 15mm x 14mm | In distribution | |
| G7730748 | Depth 11.4 mm | In distribution | |
| G7731507 | Length 17.5 mm | In distribution | |
| G7731508 | Length 18.5 mm | In distribution | |
| G7733511 | 2 | In distribution | |
| G7736527 | In distribution | ||
| 77367690 | 6DEG 9-10mm x 17mm x 16mm | Withdrawn | |
| G7734019 | Length 19.0 mm | Withdrawn | |
| G7730548 | Angle 0.0 ° | Withdrawn | |
| G7736520 | Withdrawn | ||
| G7736261 | Width 20.0 mm | Withdrawn | |
| G7734023 | Outer Diameter 4.0 mm | Withdrawn | |
| G7743509 | Outer Diameter 3.5 mm | 2 | Withdrawn |
| G7730245 | Angle 0.0 ° | Withdrawn | |
| 77302690 | 0DEG 9-10mm x 20mm x 16mm | Withdrawn | |
| G7744017 | Length 17.0 mm | Withdrawn | |
| G7733519 | Outer Diameter 3.5 mm | 2 | Withdrawn |
| 77307412 | 0DEG 11-12mm x 17mm x 14mm | Withdrawn | |
| G7730246 | Angle 0.0 ° | Withdrawn | |
| G7730528 | Withdrawn | ||
| G7730766 | Angle 0.0 ° | Withdrawn | |
| G7736266 | Depth 13.4 mm | Withdrawn | |
| G7733522 | Outer Diameter 3.5 mm | 2 | Withdrawn |
| 77307656 | 0DEG 5-6mm x 17mm x 16mm | Withdrawn | |
| G7736540 | Angle 6.0 ° | Withdrawn | |
| 77302456 | 0DEG 5-6mm x 20mm x14mm | Withdrawn | |
| G7736528 | Withdrawn | ||
| G7736766 | Width 17.0 mm | Withdrawn | |
| G7736262 | Width 20.0 mm | Withdrawn | |
| 77365456 | 6DEG 5-6mm x 15mm x 14mm | Withdrawn | |
| G7730526 | Withdrawn | ||
| G7743517 | Outer Diameter 3.5 mm | 2 | Withdrawn |
| 77365478 | 6DEG 7-8mm x 15mm x 14mm | Withdrawn | |
| G7734024 | Outer Diameter 4.0 mm | Withdrawn | |
| G7733524 | Outer Diameter 3.5 mm | 2 | Withdrawn |
| 77367612 | 6DEG 11-12mm x 17mm x16mm | Withdrawn | |
| G7736248 | Height 8.0 mm | Withdrawn | |
| G7730260 | Height 10.0 mm | Withdrawn | |
| G7743514 | Outer Diameter 3.5 mm | 2 | Withdrawn |
| G7730749 | Withdrawn | ||
| 77362678 | 6DEG 7-8mm x 20mm x 16mm | Withdrawn | |
| G7736240 | Depth 11.4 mm | Withdrawn | |
| G7736525 | Withdrawn | ||
| G7734020 | Outer Diameter 4.0 mm | Withdrawn | |
| 77362690 | 6DEG 9-10mm x 20mm x 16mm | Withdrawn | |
| G7730241 | Depth 11.4 mm | Withdrawn | |
| G7743518 | Outer Diameter 3.5 mm | 2 | Withdrawn |
| G7734011 | Withdrawn | ||
| 77302656 | 0DEG 5-6mm x 20mm x 16mm | Withdrawn | |
| G7730248 | Height 8.0 mm | Withdrawn | |
| G7736241 | Height 11.0 mm | Withdrawn | |
| G7730762 | Angle 0.0 ° | Withdrawn | |
| G7733523 | Length 23.0 mm | 2 | Withdrawn |
| G7736741 | Height 11.0 mm | Withdrawn | |
| G7733514 | Length 14.0 mm | 2 | Withdrawn |
| G7744022 | Outer Diameter 4.0 mm | Withdrawn | |
| 77362412 | 6DEG 11-12mm x 20mm x14mm | Withdrawn | |
| G7731508 | Withdrawn | ||
| G7744016 | Length 16.0 mm | Withdrawn | |
| G7730546 | Height 5.0 mm | Withdrawn | |
| G7730748 | Withdrawn | ||
| G7736546 | Depth 11.4 mm | Withdrawn | |
| G7730261 | Height 11.0 mm | Withdrawn | |
| 77305478 | 0DEG 7-8mm x 15mm x 14mm | Withdrawn | |
| G7730742 | Depth 11.4 mm | Withdrawn | |
| G7734010 | Length 10.0 mm | Withdrawn | |
| G7730767 | Depth 13.4 mm | Withdrawn | |
| G7730266 | Angle 0.0 ° | Withdrawn | |
| G7736549 | Height 9.0 mm | Withdrawn | |
| 77367678 | 6DEG 7-8mm x 17mm x 16mm | Withdrawn | |
| 77362612 | 6DEG 11-12mm x 20mm x16mm | Withdrawn | |
| 77362456 | 6DEG 5-6mm x 20mm x 14mm | Withdrawn | |
| G7744012 | Length 12.0 mm | Withdrawn | |
| G7731510 | Withdrawn | ||
| G7743524 | Outer Diameter 3.5 mm | 2 | Withdrawn |
| G7736247 | Height 7.0 mm | Withdrawn | |
| G7730525 | Withdrawn | ||
| G7734017 | Outer Diameter 4.0 mm | Withdrawn | |
| G7743519 | Outer Diameter 3.5 mm | 2 | Withdrawn |
| G7736760 | Depth 13.4 mm | Withdrawn | |
| G7744018 | Outer Diameter 4.0 mm | Withdrawn | |
| G7730240 | Depth 11.4 mm | Withdrawn | |
| G7734012 | Length 12.0 mm | Withdrawn | |
| 77305490 | 0DEG 9-10mm x 15mm x 14mm | Withdrawn | |
| G7736742 | Depth 11.4 mm | Withdrawn | |
| G7734009 | Length 9.0 mm | Withdrawn | |
| G7730529 | Withdrawn | ||
| G7736245 | Width 20.0 mm | Withdrawn | |
| G7734013 | Withdrawn | ||
| G7730540 | Depth 11.4 mm | Withdrawn | |
| G7730268 | Height 8.0 mm | Withdrawn | |
| G7744014 | Length 14.0 mm | Withdrawn | |
| 77307678 | 0DEG 7-8mm x 17mm x 16mm | Withdrawn | |
| G7743515 | 2 | Withdrawn | |
| G7744020 | Length 20.0 mm | Withdrawn | |
| 7730812 | 12mm | Withdrawn | |
| G7730541 | Height 11.0 mm | Withdrawn | |
| 77367412 | 6DEG 11-12mm x 17mm x14mm | Withdrawn | |
| G7743521 | Outer Diameter 3.5 mm | 2 | Withdrawn |
| G7730746 | Withdrawn | ||
| G7734016 | Outer Diameter 4.0 mm | Withdrawn | |
| G7743511 | 2 | Withdrawn | |
| G7730745 | Withdrawn | ||
| G7736547 | Depth 11.4 mm | Withdrawn | |
| 77365212 | 6DEG 11-12mm x 15mm x12mm | Withdrawn |
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 |
|---|---|
| K153373 | 2016-01-19 |
| K100214 | 2010-06-25 |
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.