| Primary Device ID | 00190376206677 |
| NIH Device Record Key | 9ea71c5b-6c27-407a-90a1-e86a6a925fe0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Transcend |
| Version Model Number | 101-10185500-S |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | 55 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Depth | 50 Millimeter |
| Width | 18 Millimeter |
| Height | 10 Millimeter |
| Length | 50 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376206677 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-20 |
| Device Publish Date | 2020-01-10 |
| 00190376206882 | TRANSCEND LIF PEEK SPACER, 12 x 22 x 60 mm, 0° |
| 00190376206875 | TRANSCEND LIF PEEK SPACER, 12 x 22 x 55 mm, 0° |
| 00190376206868 | TRANSCEND LIF PEEK SPACER, 12 x 22 x 50 mm, 0° |
| 00190376206851 | TRANSCEND LIF PEEK SPACER, 12 x 22 x 45 mm, 0° |
| 00190376206844 | TRANSCEND LIF PEEK SPACER, 12 x 18 x 60 mm, 0° |
| 00190376206837 | TRANSCEND LIF PEEK SPACER, 12 x 18 x 55 mm, 0° |
| 00190376206820 | TRANSCEND LIF PEEK SPACER, 12 x 18 x 50 mm, 0° |
| 00190376206813 | TRANSCEND LIF PEEK SPACER, 12 x 18 x 45 mm, 0° |
| 00190376206790 | TRANSCEND LIF PEEK SPACER, 10 x 22 x 60 mm, 0° |
| 00190376206776 | TRANSCEND LIF PEEK SPACER, 10 x 22 x 55 mm, 0° |
| 00190376206752 | TRANSCEND LIF PEEK SPACER, 10 x 22 x 50 mm, 0° |
| 00190376206738 | TRANSCEND LIF PEEK SPACER, 10 x 22 x 45 mm, 0° |
| 00190376206714 | TRANSCEND LIF PEEK SPACER, 10 x 18 x 60 mm, 0° |
| 00190376206677 | TRANSCEND LIF PEEK SPACER, 10 x 18 x 55 mm, 0° |
| 00190376206660 | TRANSCEND LIF PEEK SPACER, 10 x 18 x 50 mm, 0° |
| 00190376206653 | TRANSCEND LIF PEEK SPACER, 10 x 18 x 45 mm, 0° |
| 00190376206646 | TRANSCEND LIF PEEK SPACER, 8 x 22 x 60 mm, 10° |
| 00190376206639 | TRANSCEND LIF PEEK SPACER, 8 x 22 x 60 mm, 0° |
| 00190376206622 | TRANSCEND LIF PEEK SPACER, 8 x 22 x 55 mm, 10° |
| 00190376206615 | TRANSCEND LIF PEEK SPACER, 8 x 22 x 55 mm, 0° |
| 00190376206608 | TRANSCEND LIF PEEK SPACER, 8 x 22 x 50 mm, 10° |
| 00190376206592 | TRANSCEND LIF PEEK SPACER, 8 x 22 x 50 mm, 0° |
| 00190376206585 | TRANSCEND LIF PEEK SPACER, 8 x 22 x 45 mm, 10° |
| 00190376206578 | TRANSCEND LIF PEEK SPACER, 8 x 22 x 45 mm, 0° |
| 00190376206561 | TRANSCEND LIF PEEK SPACER, 8 x 18 x 60 mm, 10° |
| 00190376206554 | TRANSCEND LIF PEEK SPACER, 8 x 18 x 60 mm, 0° |
| 00190376206547 | TRANSCEND LIF PEEK SPACER, 8 x 18 x 55 mm, 10° |
| 00190376206530 | TRANSCEND LIF PEEK SPACER, 8 x 18 x 55 mm, 0° |
| 00190376206523 | TRANSCEND LIF PEEK SPACER, 8 x 18 x 50 mm, 10° |
| 00190376206516 | TRANSCEND LIF PEEK SPACER, 8 x 18 x 50 mm, 0° |
| 00190376206509 | TRANSCEND LIF PEEK SPACER, 8 x 18 x 45 mm, 10° |
| 00190376206493 | TRANSCEND LIF PEEK SPACER, 8 x 18 x 45 mm, 0° |
| 00190376206486 | TRANSCEND LIF PEEK SPACER, 6 x 22 x 60 mm, 10° |
| 00190376206479 | TRANSCEND LIF PEEK SPACER, 6 x 22 x 55 mm, 10° |
| 00190376206462 | TRANSCEND LIF PEEK SPACER, 6 x 22 x 50 mm, 10° |
| 00190376206455 | TRANSCEND LIF PEEK SPACER, 6 x 22 x 45 mm, 10° |
| 00190376206448 | TRANSCEND LIF PEEK SPACER, 6 x 18 x 60 mm, 10° |
| 00190376206431 | TRANSCEND LIF PEEK SPACER, 6 x 18 x 55 mm, 10° |
| 00190376206424 | TRANSCEND LIF PEEK SPACER, 6 x 18 x 50 mm, 10° |
| 00190376206417 | TRANSCEND LIF PEEK SPACER, 6 x 18 x 45 mm, 10° |
| 00190376206400 | TRANSCEND LIF PEEK SPACER, 4 x 22 x 60 mm, 10° |
| 00190376206394 | TRANSCEND LIF PEEK SPACER, 4 x 22 x 55 mm, 10° |
| 00190376206387 | TRANSCEND LIF PEEK SPACER, 4 x 22 x 50 mm, 10° |
| 00190376206370 | TRANSCEND LIF PEEK SPACER, 4 x 22 x 45 mm, 10° |
| 00190376206363 | TRANSCEND LIF PEEK SPACER, 4 x 18 x 60 mm, 10° |
| 00190376206356 | TRANSCEND LIF PEEK SPACER, 4 x 18 x 55 mm, 10° |
| 00190376206349 | TRANSCEND LIF PEEK SPACER, 4 x 18 x 50 mm, 10° |
| 00190376206332 | TRANSCEND LIF PEEK SPACER, 4 x 18 x 45 mm, 10° |
| 00190376243276 | TRANSCEND LIF PEEK SPACER, 12 x 26 x 60 mm, 10° |
| 00190376243269 | TRANSCEND LIF PEEK SPACER, 12 x 26 x 55 mm, 10° |