| Primary Device ID | 07630040729390 |
| NIH Device Record Key | 35851c47-cfb8-48ba-8a14-c1883e82d3ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SportMed Instruments |
| Version Model Number | 05.05.10.0020 |
| 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 | 07630040729390 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630040729390]
Moist Heat or Steam Sterilization
[07630040729390]
Moist Heat or Steam Sterilization
[07630040729390]
Moist Heat or Steam Sterilization
[07630040729390]
Moist Heat or Steam Sterilization
[07630040729390]
Moist Heat or Steam Sterilization
[07630040729390]
Moist Heat or Steam Sterilization
[07630040729390]
Moist Heat or Steam Sterilization
[07630040729390]
Moist Heat or Steam Sterilization
[07630040729390]
Moist Heat or Steam Sterilization
[07630040729390]
Moist Heat or Steam Sterilization
[07630040729390]
Moist Heat or Steam Sterilization
[07630040729390]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-10 |
| Device Publish Date | 2020-12-02 |
| 07630040729468 | Knee Probe |
| 07630040729451 | Hammer |
| 07630040729444 | PSP Impactor |
| 07630040729437 | Tendon Stripper Open |
| 07630040729420 | Tendon Stripper Close |
| 07630040729413 | Reverse length gauge |
| 07630040729406 | Standard length gauge |
| 07630040729390 | Tibial Aimer Bullet MEDIUM |
| 07630040729383 | Tibial Aimer Bullet SMALL |
| 07630040729376 | Tibial Aimer Arc LEFT |
| 07630040729369 | Tibial Aimer Arc RIGHT |
| 07630040729352 | Femoral Aimer 50 |
| 07630040729345 | Femoral Aimer 35 |
| 07630040729338 | Suture support |
| 07630040729321 | Tibial button support |
| 07630040729314 | Femoral button support |
| 07630040729307 | Prep Plastic board |
| 07630040729291 | Graft clamp |
| 07630040729284 | PrepTable |
| 07630040729277 | Graft Measuring Device |
| 07630040729260 | Femoral Dilator LARGE |
| 07630040729253 | Femoral Dilator MEDIUM |
| 07630040729246 | Femoral Dilator SMALL |
| 07630040729239 | Tibial Dilator LARGE |
| 07630040729222 | Tibial Dilator MEDIUM |
| 07630040729215 | Tibial Dilator SMALL |
| 07630040729208 | Slide Hammer |
| 07630040717045 | Bone Drill Ø4.5 L260 |
| 07630040717038 | Bone Drill Ø4.5 L230 |
| 07630040717021 | Acorn Reamer Ø 4.5 |
| 07630040717014 | Special K-wire |
| 07630040717007 | Passing wire Ø2.4 L380 |
| 07630040716994 | K-wire Ø2.4 L220 |
| 07630040716987 | K-wire Ø2.4 L380 |
| 07630971255692 | FastShuttle - Disposable Needle – STERILE (5x) |
| 07630971232082 | MectaFlip 150mm |
| 07630971232075 | MectaFlip 120mm |
| 07630971232068 | MectaFlip 80mm |
| 07630040731676 | Horizontal Cutter - MARS ACL MEDIUM |
| 07630040731652 | Horizontal Cutter - 15x6 |
| 07630040731645 | Horizontal Cutter - 15x5 |
| 07630040731638 | Horizontal Cutter - 15x3 |
| 07630040731621 | Horizontal Cutter - 10x4 |
| 07630040731584 | Vertical Cutter - 14x7 |
| 07630040731577 | Vertical Cutter - 14x5 |
| 07630040731560 | Vertical Cutter - 12x7 |
| 07630040731553 | Vertical Cutter - 12x5 |
| 07630040731546 | Vertical Cutter - 10x7 |
| 07630040731539 | Vertical Cutter - 10x5 |
| 07630040731522 | Vertical Cutter - 9x7 |