| Primary Device ID | 07630542715648 |
| NIH Device Record Key | 6cf746a6-0a9d-4935-ac8e-f58604d91d3e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spine instrument |
| Version Model Number | 03.75.10.0347 |
| Company DUNS | 488227125 |
| Company Name | Medacta International SA |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630542715648 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
[07630542715648]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-29 |
| Device Publish Date | 2023-12-21 |
| 07630971203488 | MIS Blade Anatomical Left 90mm |
| 07630542714245 | MUST MC Screw to Screw Distractor Post |
| 07630542714238 | MUST MC Screw to Screw Distractor |
| 07630542722387 | MUST LT Rescue Tool standard |
| 07630542722301 | MUST MC rod fork |
| 07630542714856 | LP Sleeve with Flap - one part |
| 07630542719257 | MySpine Cerv tap ø4.0 cann undersized short |
| 07630542719240 | MySpine Cerv tap ø2.7 short |
| 07630542716287 | MySpine Cervical Probe Ø3.7 -35mm Mech stop short |
| 07630542716270 | MySpine Cervical Probe Ø3.7 -20mm Mech stop short |
| 07630542716263 | MySpine Cervical Probe Ø3.2 -35mm Mech stop short |
| 07630542716256 | MySpine Cerv tap ø4.0 cann undersized short |
| 07630542716249 | MySpine Cerv tap ø3.5 cann undersized short |
| 07630542715648 | MySpine Cervical Probe Ø3.2 -20mm Mech stop short |
| 07630542714283 | MySpine Cerv Omega Drill Solid Ø2.9x16 stop long |
| 07630542714276 | MySpine Cerv Omega Drill Solid Ø2.4x16 stop long |
| 07630542714269 | MySpine Cerv Omega Drill Solid Ø2.9x16 stop short |
| 07630542714252 | MySpine Cerv Omega Drill Solid Ø2.4x16 stop short |
| 07630542703850 | MySpine Cerv Omega Drill Solid Ø2.9x25 stop long |
| 07630542703843 | MySpine Cerv Omega Drill Solid Ø2.9x20 stop long |
| 07630542703836 | MySpine Cerv Omega Drill Solid Ø2.9x14 stop long |
| 07630542703829 | MySpine Cerv Omega Drill Solid Ø2.9x12 stop long |
| 07630542703812 | MySpine Cerv Omega Drill Solid Ø2.4x25 stop long |
| 07630542703805 | MySpine Cerv Omega Drill Solid Ø2.4x20 stop long |
| 07630542703799 | MySpine Cerv Omega Drill Solid Ø2.4x14 stop long |
| 07630542703782 | MySpine Cerv Omega Drill Solid Ø2.4x12 stop long |
| 07630542703775 | MySpine Cerv Omega Drill Solid Ø2.9x25 stop short |
| 07630542703768 | MySpine Cerv Omega Drill Solid Ø2.9x20 stop short |
| 07630542703751 | MySpine Cerv Omega Drill Solid Ø2.9x14 stop short |
| 07630542703744 | MySpine Cerv Omega Drill Solid Ø2.9x12 stop short |
| 07630542703737 | MySpine Cerv Omega Drill Solid Ø2.4x25 stop short |
| 07630542703720 | MySpine Cerv Omega Drill Solid Ø2.4x20 stop short |
| 07630542703713 | MySpine Cerv Omega Drill Solid Ø2.4x14 stop short |
| 07630542703706 | MySpine Cerv Omega Drill Solid Ø2.4x12 stop short |
| 07630542719127 | MySpine Instrument Tray 2 – Cervical |
| 07630542720338 | Ratcheting T-Handle 1/4" |
| 07630542723315 | Countertorque 4 arms for Ø6 rods |
| 07630542763625 | ALIF LAG - Cover plate inserter - Bayonet Forceps |