| Primary Device ID | B587XL062260120 |
| NIH Device Record Key | 58395dc5-5d04-4316-a074-5961b5a80fb5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Yellowstone |
| Version Model Number | 1 |
| Catalog Number | XL062260-12 |
| Company DUNS | 079539689 |
| Company Name | SUMMIT SPINE LLC |
| 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 | 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 | 8772089272 |
| info@summitspineco.com |
| Angle | 12 degree |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B587XL062260120 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B587XL062260120]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-07-17 |
| B5872010030 | Dilator - Large |
| B5872010020 | Dilator - Medium |
| B5872010010 | Dilator - Small |
| B587TT15123670 | TLIF Sizing Trial 15mm H x 12mm W x 36mm L x 7 degrees |
| B587TT1512360 | TLIF Sizing Trial 15mm H x 12mm W x 36mm L |
| B587TT15123470 | TLIF Sizing Trial 15mm H x 12mm W x 34mm L x 7 degrees |
| B587TT1512340 | TLIF Sizing Trial 15mm H x 12mm W x 34mm L |
| B587TT15123270 | TLIF Sizing Trial 15mm H x 12mm W x 32mm L x 7 degrees |
| B587TT1512320 | TLIF Sizing Trial 15mm H x 12mm W x 32mm L |
| B587TT15123070 | TLIF Sizing Trial 15mm H x 12mm W x 30mm L x 7 degrees |
| B587TT1512300 | TLIF Sizing Trial 15mm H x 12mm W x 30mm L |
| B587TT15122870 | TLIF Sizing Trial 15mm H x 12mm W x 28mm L x 7 degrees |
| B587TT1512280 | TLIF Sizing Trial 15mm H x 12mm W x 28mm L |
| B587TT15122670 | TLIF Sizing Trial 15mm H x 12mm W x 26mm L x 7 degrees |
| B587TT1512260 | TLIF Sizing Trial 15mm H x 12mm W x 26mm L |
| B587TT15103670 | TLIF Sizing Trial 15mm H x 10mm W x 36mm L x 7 degrees |
| B587TT1510360 | TLIF Sizing Trial 15mm H x 10mm W x 36mm L |
| B587TT15103470 | TLIF Sizing Trial 15mm H x 10mm W x 34mm L x 7 degrees |
| B587TT1510340 | TLIF Sizing Trial 15mm H x 10mm W x 34mm L |
| B587TT15103270 | TLIF Sizing Trial 15mm H x 10mm W x 32mm L x 7 degrees |
| B587TT1510320 | TLIF Sizing Trial 15mm H x 10mm W x 32mm L |
| B587TT15103070 | TLIF Sizing Trial 15mm H x 10mm W x 30mm L x 7 degrees |
| B587TT1510300 | TLIF Sizing Trial 15mm H x 10mm W x 30mm L |
| B587TT15102870 | TLIF Sizing Trial 15mm H x 10mm W x 28mm L x 7 degrees |
| B587TT1510280 | TLIF Sizing Trial 15mm H x 10mm W x 28mm L |
| B587TT15102670 | TLIF Sizing Trial 15mm H x 10mm W x 26mm L x 7 degrees |
| B587TT1510260 | TLIF Sizing Trial 15mm H x 10mm W x 26mm L |
| B587TT1510240 | 15mm H x 10mm W x 24mm L TLIF Sizing Trial |
| B587TT1510220 | 15mm H x 10mm W x 22mm L TLIF Sizing Trial |
| B587TT1510200 | 15mm H x 10mm W x 20mm L TLIF Sizing Trial |
| B587TT14123670 | TLIF Sizing Trial 14mm H x 12mm W x 36mm L x 7 degrees |
| B587TT1412360 | TLIF Sizing Trial 14mm H x 12mm W x 36mm L |
| B587TT14123470 | TLIF Sizing Trial 14mm H x 12mm W x 34mm L x 7 degrees |
| B587TT1412340 | TLIF Sizing Trial 14mm H x 12mm W x 34mm L |
| B587TT14123270 | TLIF Sizing Trial 14mm H x 12mm H x 32mm L x 7 degrees |
| B587TT1412320 | TLIF Sizing Trial 14mm H x 12mm W x 32mm L |
| B587TT14123070 | TLIF Sizing Trial 14mm H x 12mm W x 30mm L x 7 degrees |
| B587TT1412300 | TLIF Sizing Trial 14mm H x 12mm W x 30mm L |
| B587TT14122870 | TLIF Sizing Trial 14mm H x 12mm W x 28mm L x 7 degrees |
| B587TT1412280 | TLIF Sizing Trial 14mm H x 12mm W x 28mm L |
| B587TT14122670 | TLIF Sizing Trial 14mm H x 12mm W x 26mm L x 7 degrees |
| B587TT1412260 | TLIF Sizing Trial 14mm H x 12mm W x 26mm L |
| B587TT14103670 | TLIF Sizing Trial 14mm H x 10mm W x 36mm L x 7 degrees |
| B587TT1410360 | TLIF Sizing Trial 14mm H x 10mm W x 36mm L |
| B587TT14103470 | TLIF Sizing Trial 14mm H x 10mm W x 34mm L x 7 degrees |
| B587TT1410340 | TLIF Sizing Trial 14mm H x 10mm W x 34mm L |
| B587TT14103270 | TLIF Sizing Trial 14mm H x 10mm W x 32mm L x 7 degrees |
| B587TT1410320 | TLIF Sizing Trial 14mm H x 10mm W x 32mm L |
| B587TT14103070 | TLIF Sizing Trial 14mm H x 10mm W x 30mm L x 7 degrees |
| B587TT1410300 | TLIF Sizing Trial 14mm H x 10mm W x 30mm L |