| Primary Device ID | 00190837020965 |
| NIH Device Record Key | 5f2d12d9-cc01-4515-8f2c-478ce9d9225e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dyna-Link Elite |
| Version Model Number | 81-3828-0617 |
| Company DUNS | 183641617 |
| Company Name | Life Spine, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190837020965 [Primary] |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190837020965]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2017-05-24 |
| 00190837021009 | 81-3828-1217 |
| 00190837020996 | 81-3828-1215 |
| 00190837020989 | 81-3828-1213 |
| 00190837020972 | 81-3828-1211 |
| 00190837020965 | 81-3828-0617 |
| 00190837020958 | 81-3828-0615 |
| 00190837020941 | 81-3828-0613 |
| 00190837020934 | 81-3828-0611 |
| 00190837020927 | 81-3424-1217 |
| 00190837020910 | 81-3424-1215 |
| 00190837020903 | 81-3424-1213 |
| 00190837020897 | 81-3424-1211 |
| 00190837020880 | 81-3424-0617 |
| 00190837020873 | 81-3424-0615 |
| 00190837020866 | 81-3424-0613 |
| 00190837020859 | 81-3424-0611 |
| 00190837020842 | 81-160-30 |
| 00190837020835 | 81-160-27 |
| 00190837020828 | 81-160-25 |
| 00190837020811 | 81-160-22 |
| 00190837020804 | 81-160-20 |
| 00190837020798 | 81-155-30 |
| 00190837020781 | 81-155-27 |
| 00190837020774 | 81-155-25 |
| 00190837020767 | 81-155-22 |
| 00190837020750 | 81-155-20 |
| 00190837071240 | Dyna-Link, 42mmx30mmx17mm, 12 Degree |
| 00190837071233 | Dyna-Link, 34mmx24mmx13mm, 12 Degree |
| 00190837034696 | Dyna-Link Elite Graft Packing Plate, 38x28 |