Dyna-Link Stand-Alone Anterior Lumbar System
Custom Sleeveless Angulating Hex Driver Assembly without gui
3manufacturers in China registered for this device type
172catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 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 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Life Spine, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K091301 |
| Record published | 2019-11-07 |
| 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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 125-582 | In distribution | |
| 125-057 | In distribution | |
| 125-631 | In distribution | |
| 125-184 | In distribution | |
| 80-3226-0617 | In distribution | |
| 80-255-30 | In distribution | |
| 80-155-20 | In distribution | |
| 80-3830-0611 | In distribution | |
| 125-933 | In distribution | |
| 77-255-25 | In distribution | |
| 125-202-1 | In distribution | |
| 125-362 | In distribution | |
| 125-534 | In distribution | |
| 125-597 | In distribution | |
| 77-3024-626 | In distribution | |
| 82-155-27 | In distribution | |
| 80-255-25 | In distribution | |
| 2016-0011 | In distribution | |
| 80-3830-0615 | In distribution | |
| 80-255-20 | In distribution | |
| 125-979 | In distribution | |
| 2015-0066 | In distribution | |
| 125-578 | In distribution | |
| 77-219 | In distribution | |
| 125-963 | In distribution | |
| 114-075-1 | In distribution | |
| 125-622 | In distribution | |
| 2014-0040 | In distribution | |
| 125-965 | In distribution | |
| 125-049 | In distribution | |
| 125-178 | In distribution | |
| 125-104 | In distribution | |
| 2015-0014 | In distribution | |
| 125-360 | In distribution | |
| 77-324 | In distribution | |
| 77-312 | In distribution | |
| 80-3830-0613 | In distribution | |
| 2015-0011 | In distribution | |
| 125-197 | In distribution | |
| 2015-0064 | In distribution | |
| 125-051 | In distribution | |
| 125-482 | In distribution | |
| 125-120 | In distribution | |
| 78-620 | In distribution | |
| 77-313 | In distribution | |
| 125-182 | In distribution | |
| 125-202 | In distribution | |
| 125-564 | In distribution | |
| 125-881 | In distribution | |
| 125-568 | In distribution | |
| 125-640 | In distribution | |
| 125-085 | In distribution | |
| 125-639 | In distribution | |
| 125-961 | In distribution | |
| 125-530 | In distribution | |
| 125-613 | In distribution | |
| 125-055 | In distribution | |
| 77-315 | In distribution | |
| 125-929 | In distribution | |
| 125-635 | In distribution | |
| 125-566 | In distribution | |
| 82-155-25 | In distribution | |
| 125-885 | In distribution | |
| 77-255-35 | In distribution | |
| 125-204 | In distribution | |
| 114-075-2 | In distribution | |
| 80-3830-1213 | In distribution | |
| 77-255-30 | In distribution | |
| 2016-0141 | In distribution | |
| 125-358 | In distribution | |
| 77-325 | In distribution | |
| 125-629 | In distribution | |
| 125-595 | In distribution | |
| 80-3226-1211 | In distribution | |
| 114-077 | In distribution | |
| 125-199 | In distribution | |
| 125-081 | In distribution | |
| 125-580 | In distribution | |
| 125-122 | In distribution | |
| 82-155-30 | In distribution | |
| 125-528 | In distribution | |
| 125-596 | In distribution | |
| 80-3226-0611 | In distribution | |
| 80-3830-0617 | In distribution | |
| 125-636 | In distribution | |
| 125-126 | In distribution | |
| 125-486 | In distribution | |
| 125-887 | In distribution | |
| 125-118 | In distribution | |
| 125-152 | In distribution | |
| 125-361 | In distribution | |
| 125-124 | In distribution | |
| 125-584 | In distribution | |
| 82-155-20 | In distribution | |
| 125-198 | In distribution | |
| 77-217 | In distribution | |
| 125-393 | In distribution | |
| 80-155-30 | In distribution | |
| 125-150 | In distribution | |
| 80-3830-1217 | In distribution | |
| 77-215 | In distribution | |
| 125-177 | In distribution | |
| 80-3226-1215 | In distribution | |
| 2013-0070 | In distribution | |
| 77-320 | In distribution | |
| 2013-0068 | In distribution | |
| 82-155-22 | In distribution | |
| 125-977 | In distribution | |
| 80-3830-1211 | In distribution | |
| 125-170 | In distribution | |
| 80-3830-1215 | In distribution | |
| 80-620 | In distribution | |
| 125-594 | In distribution | |
| 125-208 | In distribution | |
| 77-311 | In distribution | |
| 125-637 | In distribution | |
| 80-3226-1217 | In distribution | |
| 2013-0069 | In distribution | |
| 125-480 | In distribution | |
| 114-076 | In distribution | |
| 77-317 | In distribution | |
| 125-154 | In distribution | |
| 2016-0090-1 | In distribution | |
| 125-171 | In distribution | |
| 125-883 | In distribution | |
| 125-203 | In distribution | |
| 125-183 | In distribution | |
| 125-623 | In distribution | |
| 2015-0065 | In distribution | |
| 125-114 | In distribution | |
| 125-172 | In distribution | |
| 125-099 | In distribution | |
| 80-3226-1213 | In distribution | |
| 78-255-20 | In distribution | |
| 125-981 | In distribution | |
| 125-098 | In distribution | |
| 1125-184 | In distribution | |
| 125-935 | In distribution | |
| 125-384 | In distribution | |
| 125-614 | In distribution | |
| 77-3428-611 | In distribution | |
| 125-967 | In distribution | |
| 125-983 | In distribution | |
| 125-532 | In distribution | |
| 125-193 | In distribution | |
| 125-053 | In distribution | |
| 80-155-25 | In distribution | |
| 2015-0075 | In distribution | |
| 2016-0090 | In distribution | |
| 2016-0089 | In distribution | |
| 2015-0007 | In distribution | |
| 125-931 | In distribution | |
| 77-3428-1215 | In distribution | |
| 78-255-35 | In distribution | |
| 125-395 | In distribution | |
| 77-3428-1211 | In distribution | |
| 77-318 | In distribution | |
| 77-3428-613 | In distribution | |
| 125-083 | In distribution | |
| 77-300 | In distribution | |
| 78-255-30 | In distribution | |
| 125-602 | In distribution | |
| 125-399 | In distribution | |
| 125-634 | In distribution | |
| 77-310 | In distribution | |
| 78-255-25 | In distribution | |
| 77-302 | In distribution | |
| 80-3124-1211 | In distribution | |
| 80-3226-0615 | In distribution | |
| 2015-0067 | In distribution | |
| 80-3226-0613 | In distribution | |
| 125-562 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200338 | 2020-04-17 |
| K191834 | 2019-12-16 |
| K180215 | 2018-09-13 |
| K091301 | 2009-12-15 |
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.