| Primary Device ID | 00850011324097 |
| NIH Device Record Key | 7f4fd20d-bb0f-4414-94e3-49b79e6b849a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | L-Varlock |
| Version Model Number | 097 |
| Catalog Number | SD-4100 |
| Company DUNS | 150955560 |
| Company Name | SPINESOURCE INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850011324097 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850011324097]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-21 |
| Device Publish Date | 2019-10-11 |
| 00850011324103 | Instrument, Slap Hammer Adapter |
| 00850011324097 | Instrument, Expansion Screwdriver, Long |
| 00850011324110 | The L-Varlock is a lumbar cage, for intervertebral body fusion. |
| 00850011324127 | Instrument, Implant Stabilizer |
| 00850011324080 | Instrument, Disc Shaver, 13mm |
| 00850011324073 | Instrument, Disc Shaver, 12mm |
| 00850011324066 | Instrument, Disc Shaver, 11mm |
| 00850011324059 | Instrument, Disc Shaver, 10mm |
| 00850011324042 | Instrument, Disc Shaver, 9mm |
| 00850011324035 | Instrument, Disc Shaver, 8mm |
| 00850011324028 | Instrument, Disc Shaver, 7mm |
| 00850011324011 | Instrument, Implant Stabilizer |
| 00850011324004 | The L-Varlock is a lumbar cage, for intervertebral body fusion. |
| 00850011324134 | The L-Varlock is a lumbar cage, for intervertebral body fusion. |
| 00850011324141 | Instrument, Inserter |
| 00850011324165 | The L-Varlock is a lumbar cage, for intervertebral body fusion. |
| 00850011324158 | The L-Varlock is a lumbar cage, for intervertebral body fusion. |