Primary Device ID | 07630971254381 |
NIH Device Record Key | b136243c-04b8-4c30-a01d-420dfa890764 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Spine Instruments |
Version Model Number | 03.51.10.0431 |
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 | 07630971254381 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
[07630971254381]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-08-29 |
Device Publish Date | 2024-08-21 |
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 |