Divergence® Anterior Cervical Fusion System
Implant G6620241 NP Paral 11MMX20MMX14MM
5manufacturers in China registered for this device type
200catalogue numbers in this listing
2510(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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K141599 |
| Record published | 2015-10-02 |
| 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 | Width 15 to 20 mm; depth 12 to 16 mm; angle 0 to 6 °; height 5 to 12 mm; length 9 to 17 mm; outer diameter 3.5 to 4 mm |
| Distribution end date | 2022-11-02 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| G6623511 | Length 11.0 mm | 2 | In distribution |
| G6620747 | Depth 14.0 mm | In distribution | |
| G6626749 | Width 17.0 mm | In distribution | |
| 6620812 | Width 17.0 mm | In distribution | |
| 6628170 | Height 10.0 mm | In distribution | |
| 66265278 | Width 15.0 mm | In distribution | |
| 6628179 | Height 9.0 mm | In distribution | |
| 66265290 | H=9-10MM | In distribution | |
| G6623513 | Outer Diameter 3.5 mm | 2 | In distribution |
| 66207478 | Angle 0.0 ° | In distribution | |
| G6626740 | Depth 14.0 mm | In distribution | |
| 66262456 | Angle 6.0 ° | In distribution | |
| 6628177 | Height 7.0 mm | In distribution | |
| G6626747 | Angle 6.0 ° | In distribution | |
| G6620749 | Depth 14.0 mm | In distribution | |
| 66205278 | Angle 0.0 ° | In distribution | |
| G6626745 | Angle 6.0 ° | In distribution | |
| G6634011 | Outer Diameter 4.0 mm | In distribution | |
| 66267490 | Angle 6.0 ° | In distribution | |
| G6620748 | Height 8.0 mm | In distribution | |
| G6623517 | Length 17.0 mm | 2 | In distribution |
| 6628156 | Height 6.0 mm | In distribution | |
| 6628176 | Width 17.0 mm | In distribution | |
| G6620525 | Width 15.0 mm | In distribution | |
| 6628159 | Width 15.0 mm | In distribution | |
| G6620529 | Depth 12.0 mm | In distribution | |
| G6620520 | Angle 0.0 ° | In distribution | |
| G6626527 | Depth 12.0 mm | In distribution | |
| G6634015 | Length 15.0 mm | In distribution | |
| G6626528 | Angle 6.0 ° | In distribution | |
| 66207490 | Depth 14.0 mm | In distribution | |
| G6633513 | Length 13.0 mm | 2 | In distribution |
| G6626525 | Depth 12.0 mm | In distribution | |
| 6628158 | Width 15.0 mm | In distribution | |
| G6626746 | Depth 14.0 mm | In distribution | |
| 66265256 | Depth 12.0 mm | In distribution | |
| 6628155 | Height 5.0 mm | In distribution | |
| G6620526 | Angle 0.0 ° | In distribution | |
| 6620810 | Freehand Inserter Sleeve | In distribution | |
| G6624011 | Length 11.0 mm | In distribution | |
| 66267478 | H=7-8MM | In distribution | |
| 6628150 | Height 10.0 mm | In distribution | |
| 66267456 | Width 17.0 mm | In distribution | |
| G6633515 | Length 15.0 mm | 2 | In distribution |
| 66205256 | H=5-6MM | In distribution | |
| G6633517 | Length 17.0 mm | 2 | In distribution |
| 6628157 | Height 7.0 mm | In distribution | |
| 66207456 | Width 17.0 mm | In distribution | |
| 66262490 | Angle 6.0 ° | In distribution | |
| G6626520 | Width 15.0 mm | In distribution | |
| 66205290 | Angle 0.0 ° | In distribution | |
| G6620746 | Depth 14.0 mm | In distribution | |
| G6620745 | Angle 0.0 ° | In distribution | |
| G6626529 | Height 9.0 mm | In distribution | |
| G6620528 | Width 15.0 mm | In distribution | |
| G6633511 | Length 11.0 mm | 2 | In distribution |
| G6620527 | Height 7.0 mm | In distribution | |
| 6620800 | In distribution | ||
| G6624015 | Length 15.0 mm | In distribution | |
| G6624013 | Length 13.0 mm | In distribution | |
| 6620811 | Width 15.0 mm | In distribution | |
| G6626526 | Depth 12.0 mm | In distribution | |
| G6626748 | Height 8.0 mm | In distribution | |
| 6628175 | Height 5.0 mm | In distribution | |
| 66262478 | Width 20.0 mm | In distribution | |
| G6634013 | Outer Diameter 4.0 mm | In distribution | |
| 6630909 | In distribution | ||
| G6623515 | Length 15.0 mm | 2 | In distribution |
| 6628178 | Width 17.0 mm | In distribution | |
| G6620740 | Angle 0.0 ° | In distribution | |
| G6620241 | Height 11.0 mm | Withdrawn | |
| G6626260 | Angle 6.0 ° | Withdrawn | |
| G6634012 | Length 12.0 mm | Withdrawn | |
| 66205456 | Width 15.0 mm | Withdrawn | |
| G6626265 | Width 20.0 mm | Withdrawn | |
| G6623510 | Length 10.0 mm | 2 | Withdrawn |
| G6620246 | Depth 14.0 mm | Withdrawn | |
| G6620521 | Height 11.0 mm | Withdrawn | |
| G6620542 | Angle 0.0 ° | Withdrawn | |
| G6626266 | Height 6.0 mm | Withdrawn | |
| G6626247 | Depth 14.0 mm | Withdrawn | |
| G6626548 | Angle 6.0 ° | Withdrawn | |
| 66267690 | Angle 6.0 ° | Withdrawn | |
| 66205412 | Depth 14.0 mm | Withdrawn | |
| G6626741 | Angle 6.0 ° | Withdrawn | |
| G6626246 | Height 6.0 mm | Withdrawn | |
| 66202412 | H=11-12MM | Withdrawn | |
| G6623509 | Outer Diameter 3.5 mm | 2 | Withdrawn |
| G6626546 | Height 6.0 mm | Withdrawn | |
| G6620249 | Height 9.0 mm | Withdrawn | |
| G6620269 | Depth 16.0 mm | Withdrawn | |
| G6620541 | Width 15.0 mm | Withdrawn | |
| G6623512 | Outer Diameter 3.5 mm | 2 | Withdrawn |
| G6633510 | Depth 16.0 mm | 2 | Withdrawn |
| G6620268 | Angle 0.0 ° | Withdrawn | |
| G6620546 | Angle 0.0 ° | Withdrawn | |
| 66205212 | Depth 12.0 mm | Withdrawn | |
| G6626521 | Width 15.0 mm | Withdrawn | |
| 66265212 | H=11-12MM | Withdrawn | |
| G6626267 | Angle 6.0 ° | Withdrawn | |
| 66267612 | Angle 6.0 ° | Withdrawn | |
| 66202490 | Depth 14.0 mm | Withdrawn | |
| G6620742 | Angle 0.0 ° | Withdrawn | |
| 66202678 | Width 20.0 mm | Withdrawn | |
| G6620767 | Height 7.0 mm | Withdrawn | |
| G6626760 | Width 17.0 mm | Withdrawn | |
| G6626268 | Angle 6.0 ° | Withdrawn | |
| 6628151 | Height 11.0 mm | Withdrawn | |
| G6626545 | Height 5.0 mm | Withdrawn | |
| G6624012 | Length 12.0 mm | Withdrawn | |
| G6620248 | Depth 14.0 mm | Withdrawn | |
| G6620266 | Height 6.0 mm | Withdrawn | |
| G6634016 | Length 16.0 mm | Withdrawn | |
| G6626765 | Depth 16.0 mm | Withdrawn | |
| 66205478 | Angle 0.0 ° | Withdrawn | |
| G6626241 | Depth 14.0 mm | Withdrawn | |
| G6626769 | Angle 6.0 ° | Withdrawn | |
| G6620262 | Width 20.0 mm | Withdrawn | |
| 66267678 | H=7-8MM | Withdrawn | |
| 6628152 | Width 15.0 mm | Withdrawn | |
| 66262656 | H=5-6MM | Withdrawn | |
| G6634017 | Length 17.0 mm | Withdrawn | |
| G6623516 | Length 16.0 mm | 2 | Withdrawn |
| G6620769 | Height 9.0 mm | Withdrawn | |
| G6620762 | Height 12.0 mm | Withdrawn | |
| G6634009 | Outer Diameter 4.0 mm | Withdrawn | |
| 66205490 | Angle 0.0 ° | Withdrawn | |
| G6620548 | Height 8.0 mm | Withdrawn | |
| G6620240 | Width 20.0 mm | Withdrawn | |
| G6624010 | Outer Diameter 4.0 mm | Withdrawn | |
| G6620245 | Height 5.0 mm | Withdrawn | |
| 66207690 | Angle 0.0 ° | Withdrawn | |
| G6626245 | Width 20.0 mm | Withdrawn | |
| G6620261 | Depth 16.0 mm | Withdrawn | |
| 66265456 | Angle 6.0 ° | Withdrawn | |
| 66207612 | Angle 0.0 ° | Withdrawn | |
| 66262690 | H=9-10MM | Withdrawn | |
| G6626767 | Height 7.0 mm | Withdrawn | |
| 66262612 | Depth 16.0 mm | Withdrawn | |
| G6620761 | Angle 0.0 ° | Withdrawn | |
| G6620242 | Angle 0.0 ° | Withdrawn | |
| G6634010 | Length 10.0 mm | Withdrawn | |
| G6626761 | Height 11.0 mm | Withdrawn | |
| 6628171 | Height 11.0 mm | Withdrawn | |
| G6620267 | Width 20.0 mm | Withdrawn | |
| G6626768 | Depth 16.0 mm | Withdrawn | |
| 66262678 | Width 20.0 mm | Withdrawn | |
| G6634014 | Length 14.0 mm | Withdrawn | |
| G6626261 | Angle 6.0 ° | Withdrawn | |
| 66202656 | Depth 16.0 mm | Withdrawn | |
| G6626742 | Height 12.0 mm | Withdrawn | |
| G6620545 | Depth 14.0 mm | Withdrawn | |
| G6620540 | Height 10.0 mm | Withdrawn | |
| G6620547 | Angle 0.0 ° | Withdrawn | |
| G6624017 | Outer Diameter 4.0 mm | Withdrawn | |
| G6620768 | Angle 0.0 ° | Withdrawn | |
| G6620265 | Angle 0.0 ° | Withdrawn | |
| G6626262 | Height 12.0 mm | Withdrawn | |
| G6620741 | Angle 0.0 ° | Withdrawn | |
| 66202612 | Width 20.0 mm | Withdrawn | |
| 66207678 | Width 17.0 mm | Withdrawn | |
| G6626242 | Height 12.0 mm | Withdrawn | |
| G6620260 | Angle 0.0 ° | Withdrawn | |
| 66265478 | Width 15.0 mm | Withdrawn | |
| G6626522 | Height 12.0 mm | Withdrawn | |
| 66202690 | Angle 0.0 ° | Withdrawn | |
| 66202478 | Width 20.0 mm | Withdrawn | |
| G6620766 | Width 17.0 mm | Withdrawn | |
| G6626762 | Angle 6.0 ° | Withdrawn | |
| G6626240 | Width 20.0 mm | Withdrawn | |
| 66262412 | Angle 6.0 ° | Withdrawn | |
| G6623514 | Length 14.0 mm | 2 | Withdrawn |
| G6633516 | Length 16.0 mm | 2 | Withdrawn |
| 66202456 | Angle 0.0 ° | Withdrawn | |
| G6620247 | Height 7.0 mm | Withdrawn | |
| G6633512 | Length 12.0 mm | 2 | Withdrawn |
| G6626547 | Angle 6.0 ° | Withdrawn | |
| G6633514 | Length 14.0 mm | 2 | Withdrawn |
| G6620765 | Angle 0.0 ° | Withdrawn | |
| G6624009 | Outer Diameter 4.0 mm | Withdrawn | |
| G6624014 | Length 14.0 mm | Withdrawn | |
| 66265412 | H=11-12MM | Withdrawn | |
| 66207412 | Width 17.0 mm | Withdrawn | |
| 66207656 | Depth 16.0 mm | Withdrawn | |
| G6620549 | Depth 14.0 mm | Withdrawn | |
| 66267412 | Width 17.0 mm | Withdrawn | |
| G6620760 | Angle 0.0 ° | Withdrawn | |
| G6624016 | Outer Diameter 4.0 mm | Withdrawn | |
| G6626766 | Depth 16.0 mm | Withdrawn | |
| 66267656 | H=5-6MM | Withdrawn | |
| G6626541 | Angle 6.0 ° | Withdrawn | |
| G6626542 | Width 15.0 mm | Withdrawn | |
| G6626249 | Angle 6.0 ° | Withdrawn | |
| G6626248 | Depth 14.0 mm | Withdrawn | |
| 66265490 | Angle 6.0 ° | Withdrawn | |
| G6633509 | Height 9.0 mm | 2 | Withdrawn |
| G6626269 | Height 9.0 mm | Withdrawn | |
| 6628172 | Height 12.0 mm | Withdrawn | |
| G6620522 | Height 12.0 mm | Withdrawn | |
| G6626540 | Depth 14.0 mm | Withdrawn |
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 |
|---|---|
| K113252 | 2012-01-17 |
| K094042 | 2010-06-30 |
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.