| Primary Device ID | 08800089441280 |
| NIH Device Record Key | ea132fe6-d1e2-4a2a-8ed4-2d3ffc810798 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Xpine Spinal Fixation System |
| Version Model Number | L69-RP60A-4030 |
| Company DUNS | 688811603 |
| Company Name | Jeil Medical Corporation |
| 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 | true |
| 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 | 08800089441280 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
[08800089441280]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-21 |
| Device Publish Date | 2024-11-13 |