| Primary Device ID | 00850018366328 |
| NIH Device Record Key | e5683073-1a05-4793-8b01-15416aeeef44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tailored-C |
| Version Model Number | BC4-1618-7 |
| Company DUNS | 056684302 |
| Company Name | BESPOKE TECHNOLOGIES, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850018366328 [Primary] |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-31 |
| Device Publish Date | 2025-03-21 |
| 00850018366410 | ANTERIOR CERVICAL 3DTI IMPLANT 16x18x10MM - 7° |
| 00850018366403 | ANTERIOR CERVICAL 3DTI IMPLANT 16x18x9MM - 7° |
| 00850018366397 | ANTERIOR CERVICAL 3DTI IMPLANT 16x18x8MM - 7° |
| 00850018366380 | ANTERIOR CERVICAL 3DTI IMPLANT 16x18x7MM - 7° |
| 00850018366373 | ANTERIOR CERVICAL 3DTI IMPLANT 16x18x6MM - 7° |
| 00850018366366 | ANTERIOR CERVICAL 3DTI IMPLANT 16x18x5MM - 7° |
| 00850018366359 | ANTERIOR CERVICAL 3DTI IMPLANT 16x18x10MM - 4° |
| 00850018366342 | ANTERIOR CERVICAL 3DTI IMPLANT 16x18x9MM - 4° |
| 00850018366335 | ANTERIOR CERVICAL 3DTI IMPLANT 16x18x8MM - 4° |
| 00850018366328 | ANTERIOR CERVICAL 3DTI IMPLANT 16x18x7MM - 4° |
| 00850018366311 | ANTERIOR CERVICAL 3DTI IMPLANT 16x18x6MM - 4° |
| 00850018366304 | ANTERIOR CERVICAL 3DTI IMPLANT 16x18x5MM - 4° |
| 00850018366298 | ANTERIOR CERVICAL 3DTI IMPLANT 14x16x10MM - 7° |
| 00850018366281 | ANTERIOR CERVICAL 3DTI IMPLANT 14x16x9MM - 7° |
| 00850018366274 | ANTERIOR CERVICAL 3DTI IMPLANT 14x16x8MM - 7° |
| 00850018366267 | ANTERIOR CERVICAL 3DTI IMPLANT 14x16x7MM - 7° |
| 00850018366250 | ANTERIOR CERVICAL 3DTI IMPLANT 14x16x6MM - 7° |
| 00850018366243 | ANTERIOR CERVICAL 3DTI IMPLANT 14x16x5MM - 7° |
| 00850018366236 | ANTERIOR CERVICAL 3DTI IMPLANT 14x16x10MM - 4° |
| 00850018366229 | ANTERIOR CERVICAL 3DTI IMPLANT 14x16x9MM - 4° |
| 00850018366212 | ANTERIOR CERVICAL 3DTI IMPLANT 14x16x8MM - 4° |
| 00850018366205 | ANTERIOR CERVICAL 3DTI IMPLANT 14x16x7MM - 4° |
| 00850018366199 | ANTERIOR CERVICAL 3DTI IMPLANT 14x16x6MM - 4° |
| 00850018366182 | ANTERIOR CERVICAL 3DTI IMPLANT 14x16x5MM - 4° |
| 00850018366175 | ANTERIOR CERVICAL 3DTI IMPLANT 12x14x10MM - 7° |
| 00850018366168 | ANTERIOR CERVICAL 3DTI IMPLANT 12x14x9MM - 7° |
| 00850018366151 | ANTERIOR CERVICAL 3DTI IMPLANT 12x14x8MM - 7° |
| 00850018366144 | ANTERIOR CERVICAL 3DTI IMPLANT 12x14x7MM - 7° |
| 00850018366137 | ANTERIOR CERVICAL 3DTI IMPLANT 12x14x6MM - 7° |
| 00850018366120 | ANTERIOR CERVICAL 3DTI IMPLANT 12x14x5MM - 7° |
| 00850018366113 | ANTERIOR CERVICAL 3DTI IMPLANT 12x14x10MM - 4° |
| 00850018366106 | ANTERIOR CERVICAL 3DTI IMPLANT 12x14x9MM - 4° |
| 00850018366090 | ANTERIOR CERVICAL 3DTI IMPLANT 12x14x8MM - 4° |
| 00850018366083 | ANTERIOR CERVICAL 3DTI IMPLANT 12x14x7MM - 4° |
| 00850018366076 | ANTERIOR CERVICAL 3DTI IMPLANT 12x14x6MM - 4° |
| 00850018366069 | ANTERIOR CERVICAL 3DTI IMPLANT 12x14x5MM - 4° |
| 00850018366427 | ANTERIOR CERVICAL 3DTI INSERTER WITH STOP |
| 00850018366007 | ANTERIOR CERVICAL 3DTI INSERTER |