| Primary Device ID | M7401001054 |
| NIH Device Record Key | c16c78d3-3c5c-41bd-a9e7-b02acb0137cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elite Expandable Interbody Fusion System |
| Version Model Number | 101-80-01 |
| Catalog Number | 100-1054 |
| Company DUNS | 033014361 |
| Company Name | SPINEOLOGY INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(651)256-8500 |
| info@spineology.com |
| Width | 10 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7401001054 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M7401001054]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-18 |
| Device Publish Date | 2020-02-10 |
| M7401001054 | Elite Inserter Fork |
| M7401001249 | Asm, 10 mm Fork |
| M7405409401 | Torque-Limit Handle |
| M7405408951 | Elite Release Tool |
| M7403010176 | 7mm Paddle Distractor |
| M7403010095 | 9mm Paddle Distractor |
| M7403010094 | 8mm Paddle Distractor |
| M7403010031 | 16mm Paddle Distractor |
| M7403010030 | 15mm Paddle Distractor |
| M7403010029 | 14mm Paddle Distractor |
| M7403010028 | 13mm Paddle Distractor |
| M7403010027 | 12mm Paddle Distractor |
| M7403010026 | 11mm Paddle Distractor |
| M7403010025 | 10mm Paddle Distractor |
| M7403010022 | T-Handle |
| M7403010013 | Mallet |
| M7402800051 | Slap Hammer |