| Primary Device ID | 03662663007528 |
| NIH Device Record Key | 70189b60-fac7-4378-b728-61452802879a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpineTune TL |
| Version Model Number | ST4211T-S |
| Company DUNS | 615789729 |
| Company Name | LDR Spine Usa, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 80 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03662663007528 [Primary] |
| MNI | Orthosis, Spinal Pedicle Fixation |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-03-10 |
| Device Publish Date | 2015-10-24 |