| Primary Device ID | 07630971216624 |
| NIH Device Record Key | 56559ed4-9940-4f92-a8a6-ccafb762f76b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spine Instruments |
| Version Model Number | 03.22.10.0020 |
| 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 | false |
| 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 | 07630971216624 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630971216624]
Moist Heat or Steam Sterilization
[07630971216624]
Moist Heat or Steam Sterilization
[07630971216624]
Moist Heat or Steam Sterilization
[07630971216624]
Moist Heat or Steam Sterilization
[07630971216624]
Moist Heat or Steam Sterilization
[07630971216624]
Moist Heat or Steam Sterilization
[07630971216624]
Moist Heat or Steam Sterilization
[07630971216624]
Moist Heat or Steam Sterilization
[07630971216624]
Moist Heat or Steam Sterilization
[07630971216624]
Moist Heat or Steam Sterilization
[07630971216624]
Moist Heat or Steam Sterilization
[07630971216624]
Moist Heat or Steam Sterilization
[07630971216624]
Moist Heat or Steam Sterilization
[07630971216624]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-15 |
| Device Publish Date | 2020-07-07 |
| 07630971216785 | MectaLIF Oblique Trial 15mm 0° |
| 07630971216778 | MectaLIF Oblique Trial 13mm 0° |
| 07630971216761 | MectaLIF Oblique Trial 11mm 0° |
| 07630971216754 | MectaLIF Oblique Trial 9mm 0° |
| 07630971216747 | MectaLIF Posterior Trial 15mm 10° |
| 07630971216730 | MectaLIF Posterior Trial 13mm 10° |
| 07630971216723 | MectaLIF Posterior Trial 11mm 10° |
| 07630971216716 | MectaLIF Posterior Trial 9mm 10° |
| 07630971216709 | MectaLIF Posterior Trial 25mmx15mm 0° |
| 07630971216693 | MectaLIF Posterior Trial 25mmx13mm 0° |
| 07630971216686 | MectaLIF Posterior Trial 25mmx11mm 0° |
| 07630971216679 | MectaLIF Posterior Trial 25mmx9mm 0° |
| 07630971216662 | MectaLIF Posterior Trial 25mmx7mm 0° |
| 07630971216655 | MectaLIF Implant Tray - 5 Levels |
| 07630971216648 | MectaLIF Bone Graft Impactor - Flat |
| 07630971216631 | MectaLIF Bone Graft Impactor - Angled |
| 07630971216624 | MectaLIF Bone Graft Impactor - Curved |
| 07630971216617 | MectaLIF Bone Graft Impactor - Straight |
| 07630971216600 | MectaLIF Oblique Implant Impactor |
| 07630971216594 | MectaLIF Posterior Implant Impactor |
| 07630971216563 | MectaLIF Hammer |
| 07630971216556 | MectaLIF Bone Filler Block |
| 07630971216549 | MectaLIF Oblique Inserter incl. Inner Rod |
| 07630971216532 | MectaLIF Posterior Inserter incl. Inner Rod |
| 07630971216525 | MectaLIF Oblique Trial 15mm 5° |
| 07630971216518 | MectaLIF Oblique Trial 13mm 5° |
| 07630971216501 | MectaLIF Oblique Trial 11mm 5° |
| 07630971216495 | MectaLIF Oblique Trial 9mm 5° |
| 07630971216488 | MectaLIF Oblique Trial 7mm 0° |
| 07630040788861 | MectaLIF Implant Remover |
| 07630040788854 | MectaLIF Oblique Trial 15mm 10° |
| 07630040788847 | MectaLIF Oblique Trial 13mm 10° |
| 07630040785761 | MectaLIF Posterior Trial 25mmx15mm 5° |
| 07630040785754 | MectaLIF Posterior Trial 25mmx13mm 5° |
| 07630040785747 | MectaLIF Posterior Trial 25mmx11mm 5° |
| 07630040785730 | MectaLIF Posterior Trial 25mmx9mm 5° |
| 07630040785723 | MectaLIF Posterior Trial 25mmx7mm 5° |
| 07630971200593 | Shaver 15mm / 210 mm - Left |
| 07630971200586 | Shaver 13mm / 210 mm - Left |
| 07630971200579 | Shaver 11mm / 210 mm - Left |
| 07630971200562 | Shaver 9mm / 210 mm - Left |
| 07630971200555 | Shaver 8mm / 210 mm - Left |
| 07630971200548 | Shaver 7mm / 210 mm - Left |
| 07630971200531 | Shaver 15mm / 210 mm - Right |
| 07630971200524 | Shaver 13mm / 210 mm - Right |
| 07630971200517 | Shaver 11mm / 210 mm - Right |
| 07630971200500 | Shaver 9mm / 210 mm - Right |
| 07630971200494 | Shaver 8mm / 210 mm - Right |
| 07630971200487 | Shaver 7mm / 210 mm - Right |
| 07630971200470 | Rasp Right - 45° Angled - Short |