| Primary Device ID | 07630040726825 |
| NIH Device Record Key | 684832e6-e0af-4e95-a453-afa1104d63a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACDF Stand Alone Cervical |
| Version Model Number | 03.18.704 |
| 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 | 07630040726825 [Primary] |
| OVE | Intervertebral Fusion Device With Integrated Fixation, 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 | 2020-07-06 |
| Device Publish Date | 2020-06-26 |
| 07630040726368 | Mecta-C SA – Plate Hybrid Lag h10 |
| 07630040726351 | Mecta-C SA – Plate Hybrid Lag h9 |
| 07630040726344 | Mecta-C SA – Plate Hybrid Lag h8 |
| 07630040726337 | Mecta-C SA – Plate Hybrid Lag h7 |
| 07630040726320 | Mecta-C SA – Plate Hybrid Lag h6 |
| 07630040724739 | Mecta-C SA PEEK Cage 15x13x5x7° |
| 07630040725729 | Mecta-C SA TiPEEK Cage 18x15x6x7° |
| 07630040725712 | Mecta-C SA TiPEEK Cage 18x15x5x7° |
| 07630040725705 | Mecta-C SA TiPEEK Cage 16x14x12x7° |
| 07630040725699 | Mecta-C SA TiPEEK Cage 16x14x11x7° |
| 07630040725682 | Mecta-C SA TiPEEK Cage 16x14x10x7° |
| 07630040725675 | Mecta-C SA TiPEEK Cage 16x14x9x7° |
| 07630040725668 | Mecta-C SA TiPEEK Cage 16x14x8x7° |
| 07630040725651 | Mecta-C SA TiPEEK Cage 16x14x7x7° |
| 07630040725644 | Mecta-C SA TiPEEK Cage 16x14x6x7° |
| 07630040725637 | Mecta-C SA TiPEEK Cage 16x14x5x7° |
| 07630040725620 | Mecta-C SA TiPEEK Cage 15x13x12x7° |
| 07630040725613 | Mecta-C SA TiPEEK Cage 15x13x11x7° |
| 07630040725606 | Mecta-C SA TiPEEK Cage 15x13x10x7° |
| 07630040725590 | Mecta-C SA TiPEEK Cage 15x13x9x7° |
| 07630040725583 | Mecta-C SA TiPEEK Cage 15x13x8x7° |
| 07630040725576 | Mecta-C SA TiPEEK Cage 15x13x7x7° |
| 07630040725569 | Mecta-C SA TiPEEK Cage 15x13x6x7° |
| 07630040725552 | Mecta-C SA TiPEEK Cage 15x13x5x7° |
| 07630040725545 | Mecta-C SA PEEK Cage 18x15x12x7° |
| 07630040725538 | Mecta-C SA PEEK Cage 18x15x11x7° |
| 07630971240803 | Mecta-C SA Antibackout Trio h9-h12 |
| 07630971240797 | Mecta-C SA Antibackout Trio h7-h8 |
| 07630971238282 | Mecta-C SA Antibackout Hybrid |
| 07630971238275 | Mecta-C SA Antibackout Quattro h9-h12 |
| 07630971238268 | Mecta-C SA Antibackout Quattro h5-h8 |
| 07630971238251 | Mecta-C SA Antibackout Trio h5-h6 |
| 07630971238244 | Mecta-C SA Antibackout Flush h9-h12 |
| 07630971238237 | Mecta-C SA Antibackout Flush h6-h8 |
| 07630040732390 | Mecta-C SA Tap Screw Lag Ø4.2x22 (2x) |
| 07630040732383 | Mecta-C SA Tap Screw Lag Ø3.8x22 (2x) |
| 07630040732376 | Mecta-C SA Tap Screw Lock Ø4.2x22 (2x) |
| 07630040732369 | Mecta-C SA Tap Screw Lock Ø3.8x22 (2x) |
| 07630040732352 | Mecta-C SA Tap Screw Lag Ø4.2x22 (1x) |
| 07630040732345 | Mecta-C SA Tap Screw Lag Ø3.8x22 (1x) |
| 07630040732338 | Mecta-C SA Tap Screw Lock Ø4.2x22 (1x) |
| 07630040732321 | Mecta-C SA Tap Screw Lock Ø3.8x22 (1x) |
| 07630040727181 | Mecta-C SA Tap Screw Lag Ø4.2x20 (2x) |
| 07630040727174 | Mecta-C SA Tap Screw Lag Ø4.2x18 (2x) |
| 07630040727167 | Mecta-C SA Tap Screw Lag Ø4.2x16 (2x) |
| 07630040727150 | Mecta-C SA Tap Screw Lag Ø4.2x14 (2x) |
| 07630040727143 | Mecta-C SA Tap Screw Lag Ø4.2x12 (2x) |
| 07630040727136 | Mecta-C SA Tap Screw Lag Ø3.8x20 (2x) |
| 07630040727129 | Mecta-C SA Tap Screw Lag Ø3.8x18 (2x) |
| 07630040727112 | Mecta-C SA Tap Screw Lag Ø3.8x16 (2x) |