| Primary Device ID | 07630542728631 |
| NIH Device Record Key | 7026d7be-483a-4262-8886-e486c0d93637 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgical Manual Instrument |
| Version Model Number | 02.18.10.0666 |
| 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 | 07630542728631 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630542728631]
Moist Heat or Steam Sterilization
[07630542728631]
Moist Heat or Steam Sterilization
[07630542728631]
Moist Heat or Steam Sterilization
[07630542728631]
Moist Heat or Steam Sterilization
[07630542728631]
Moist Heat or Steam Sterilization
[07630542728631]
Moist Heat or Steam Sterilization
[07630542728631]
Moist Heat or Steam Sterilization
[07630542728631]
Moist Heat or Steam Sterilization
[07630542728631]
Moist Heat or Steam Sterilization
[07630542728631]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-16 |
| Device Publish Date | 2025-09-08 |
| 07630971254466 | Femoral Impactor/Extractor S4-7 |
| 07630345785626 | Tap for Glenoid Polyaxial screw |
| 07630542721373 | MUST LT distractor frame |
| 07630542731044 | Tibia stylus 2/8 with button |
| 07630542750281 | +2mm Recut Anatomic Correction Guide |
| 07630542769221 | Ramp Inserter Oblique 10mm adaptor |
| 07630542767364 | Ramp Inserter Threaded Shaft |
| 07630542761942 | Antirotational adaptor OLIF W10 Ramp Inserter |
| 07630542761935 | Antirotational adaptor PLIF W9 Ramp Inserter |
| 07630542761928 | Ramp Inserter Inner Bush Assembly |
| 07630542761911 | Ramp Inserter Handle |
| 07630542761850 | MectaLIF Oblique Trial 3D 12x40x15 L20° |
| 07630542761843 | MectaLIF Oblique Trial 3D 12x40x15 L15° |
| 07630542761836 | MectaLIF Oblique Trial 3D 12x40x14 L15° |
| 07630542761829 | MectaLIF Oblique Trial 3D 12x40x13 L15° |
| 07630542761812 | MectaLIF Oblique Trial 3D 12x40x15 L10° |
| 07630542761805 | MectaLIF Oblique Trial 3D 12x40x14 L10° |
| 07630542761799 | MectaLIF Oblique Trial 3D 12x40x13 L10° |
| 07630542761782 | MectaLIF Oblique Trial 3D 12x40x12 L10° |
| 07630542761775 | MectaLIF Oblique Trial 3D 12x40x11 L10° |
| 07630542761768 | MectaLIF Oblique Trial 3D 12x40x10 L10° |
| 07630542761751 | MectaLIF Oblique Trial 3D 12x40x15 L5° |
| 07630542761744 | MectaLIF Oblique Trial 3D 12x40x14 L5° |
| 07630542761737 | MectaLIF Oblique Trial 3D 12x40x13 L5° |
| 07630542761720 | MectaLIF Oblique Trial 3D 12x40x12 L5° |
| 07630542761713 | MectaLIF Oblique Trial 3D 12x40x11 L5° |
| 07630542761706 | MectaLIF Oblique Trial 3D 12x40x10 L5° |
| 07630542761690 | MectaLIF Oblique Trial 3D 12x40x9 L5° |
| 07630542761683 | MectaLIF Oblique Trial 3D 12x40x8 L5° |
| 07630542761676 | MectaLIF Oblique Trial 3D 12x40x15 L0° |
| 07630542761669 | MectaLIF Oblique Trial 3D 12x40x14 L0° |
| 07630542761652 | MectaLIF Oblique Trial 3D 12x40x13 L0° |
| 07630542761645 | MectaLIF Oblique Trial 3D 12x40x12 L0° |
| 07630542761638 | MectaLIF Oblique Trial 3D 12x40x11 L0° |
| 07630542761621 | MectaLIF Oblique Trial 3D 12x40x10 L0° |
| 07630542761614 | MectaLIF Oblique Trial 3D 12x40x9 L0° |
| 07630542761607 | MectaLIF Oblique Trial 3D 12x40x8 L0° |
| 07630542761591 | MectaLIF Oblique Trial 3D 12x40x7 L0° |
| 07630542761584 | MectaLIF Oblique Trial 3D 12x36x15 L20° |
| 07630542761577 | MectaLIF Oblique Trial 3D 12x36x14 L20° |
| 07630542761560 | MectaLIF Oblique Trial 3D 12x36x15 L15° |
| 07630542761553 | MectaLIF Oblique Trial 3D 12x36x14 L15° |
| 07630542761546 | MectaLIF Oblique Trial 3D 12x36x13 L15° |
| 07630542761539 | MectaLIF Oblique Trial 3D 12x36x12 L15° |
| 07630542761522 | MectaLIF Oblique Trial 3D 12x36x11 L15° |
| 07630542761515 | MectaLIF Oblique Trial 3D 12x36x15 L10° |
| 07630542761508 | MectaLIF Oblique Trial 3D 12x36x14 L10° |
| 07630542761492 | MectaLIF Oblique Trial 3D 12x36x13 L10° |
| 07630542761485 | MectaLIF Oblique Trial 3D 12x36x12 L10° |
| 07630542761478 | MectaLIF Oblique Trial 3D 12x36x11 L10° |