| Primary Device ID | 07630040716697 |
| NIH Device Record Key | 38ac09d5-bb81-4e47-80b8-1ad89ed1b933 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | My Spine guides |
| Version Model Number | 7.0537S |
| Company DUNS | 488227125 |
| Company Name | Medacta International SA |
| 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 | 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 | 07630040716697 [Primary] |
| PQC | Pedicle screw placement guide |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-30 |
| Device Publish Date | 2026-01-22 |
| 07630040717588 | MySpine-MC drill guide S01 STERILE |
| 07630040717564 | MySpine-MC drill guide L05 STERILE |
| 07630040717540 | MySpine-MC drill guide L04 STERILE |
| 07630040717526 | MySpine-MC drill guide L03 Sterile |
| 07630040717502 | MySpine-MC drill guide L02 STERILE |
| 07630040717489 | MySpine-MC drill guide L01 STERILE |
| 07630040717465 | MySpine-MC guide S01 STERILE |
| 07630040717441 | MySpine-MC guide L05 STERILE |
| 07630040717427 | MySpine-MC guide L04 STERILE |
| 07630040717403 | MySpine-MC guide L03 STERILE |
| 07630040717380 | MySpine-MC guide L02 STERILE |
| 07630040717366 | MySpine-MC guide L01 STERILE |
| 07630040717342 | MySpine-MC vertebra S01 STERILE |
| 07630040717328 | MySpine-MC vertebra L05 STERILE |
| 07630040717304 | MySpine-MC vertebra L04 STERILE |
| 07630040717281 | MySpine-MC vertebra L03 STERILE |
| 07630040717267 | MySpine-MC vertebra L02 STERILE |
| 07630040717243 | MySpine-MC vertebra L01 STERILE |
| 07630040716895 | MySpine LP drill pilot guide L05 STERILE |
| 07630040716871 | MySpine LP drill pilot guide L04 STERILE |
| 07630040716857 | MySpine LP drill pilot guide L03 STERILE |
| 07630040716833 | MySpine LP drill pilot guide L02 STERILE |
| 07630040716819 | MySpine LP drill pilot guide L01 STERILE |
| 07630040716796 | MySpine LP drill pilot guide T12 STERILE |
| 07630040716772 | MySpine LP drill pilot guide T11 STERILE |
| 07630040716758 | MySpine LP drill pilot guide T10 STERILE |
| 07630040716734 | MySpine LP drill pilot guide T09 STERILE |
| 07630040716710 | MySpine LP drill pilot guide T08 STERILE |
| 07630040716697 | MySpine LP drill pilot guide T07 STERILE |
| 07630040716673 | MySpine LP drill pilot guide T06 STERILE |
| 07630040716659 | MySpine LP drill pilot guide T05 STERILE |
| 07630040716635 | MySpine LP drill pilot guide T04 STERILE |
| 07630040716611 | MySpine LP drill pilot guide T03 STERILE |
| 07630040716598 | MySpine LP drill pilot guide T02 STERILE |
| 07630040716574 | MySpine LP drill pilot guide T01 STERILE |