| Primary Device ID | 07630971200517 | 
| NIH Device Record Key | 81af0edf-1ced-42f1-824a-6b27a7be50a0 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Spine Instruments | 
| Version Model Number | 03.22.10.1013 | 
| 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 | 07630971200517 [Primary] | 
| LXH | Orthopedic Manual Surgical Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[07630971200517]
Moist Heat or Steam Sterilization
[07630971200517]
Moist Heat or Steam Sterilization
[07630971200517]
Moist Heat or Steam Sterilization
[07630971200517]
Moist Heat or Steam Sterilization
[07630971200517]
Moist Heat or Steam Sterilization
[07630971200517]
Moist Heat or Steam Sterilization
[07630971200517]
Moist Heat or Steam Sterilization
[07630971200517]
Moist Heat or Steam Sterilization
[07630971200517]
Moist Heat or Steam Sterilization
[07630971200517]
Moist Heat or Steam Sterilization
[07630971200517]
Moist Heat or Steam Sterilization
[07630971200517]
Moist Heat or Steam Sterilization
[07630971200517]
Moist Heat or Steam Sterilization
[07630971200517]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-07-17 | 
| Device Publish Date | 2020-07-09 | 
| 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 |