| Primary Device ID | 00840124504059 |
| NIH Device Record Key | 60a914cc-5b8d-4aea-afc7-e46c2e92661e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PolyLock Midfoot |
| Version Model Number | MF-NL-4030 |
| Catalog Number | MF-NL-4030 |
| Company DUNS | 080307067 |
| Company Name | FUSION ORTHOPEDICS, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840124504059 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840124504059]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-02-19 |
| Device Publish Date | 2021-04-20 |
| 00840124502628 | Lapidus Plate Neutral Left |
| 00840124502611 | Maverick Lapidus Plate 2mm Right |
| 00840124502604 | Maverick Lapidus Plate 2mm Left |
| 00840124502598 | Maverick Lapidus Plate Neutral Right |
| 00840124502581 | Maverick Lapidus Plate Neutral Left |
| 00840124502574 | Straight Plate Compression 8 Hole |
| 00840124502567 | Straight Plate Compression 6 Hole |
| 00840124502550 | Straight Plate Compression 5 Hole |
| 00840124502543 | Straight Plate Static 4 Hole |
| 00840124502536 | Straight Plate Compression 2 Hole |
| 00840124502529 | Straight Plate Static 2 Hole |
| 00840124502512 | Straight Plate Compression 2 Hole |
| 00840124502659 | Lapidus Plate 1mm Right |
| 00840124502642 | Lapidus Plate 1mm Left |
| 00840124502635 | Lapidus Plate Neutral Right |
| 00840124504899 | Lag Plate 4 Hole |
| 00840124503137 | Tapper Threaded Locking Screw 2.7mm x 19mm |
| 00840124503120 | Tapper Threaded Locking Screw 2.7mm x 18mm |
| 00840124503113 | Tapper Threaded Locking Screw 2.7mm x 17mm |
| 00840124503106 | Tapper Threaded Locking Screw 2.7mm x 16mm |
| 00840124503090 | Tapper Threaded Locking Screw 2.7mm x 15mm |
| 00840124503083 | Tapper Threaded Locking Screw 2.7mm x 14mm |
| 00840124503076 | Tapper Threaded Locking Screw 2.7mm x 13mm |
| 00840124503069 | Tapper Threaded Locking Screw 2.7mm x 12mm |
| 00840124503052 | Tapper Threaded Locking Screw 2.7mm x 11mm |
| 00840124503045 | Tapper Threaded Locking Screw 2.7mm x 10mm |
| 00840124503038 | Tapper Threaded Locking Screw 2.7mm x 9mm |
| 00840124503021 | Tapper Threaded Locking Screw 2.7mm x 8mm |
| 00840124502956 | LisFranc Plate Small Left |
| 00840124502949 | LisFranc Plate Small Right |
| 00840124502932 | LisFranc Plate Medium Left |
| 00840124502925 | LisFranc Plate Medium Right |
| 00840124502918 | LisFranc Plate Large Left |
| 00840124502901 | LisFranc Plate Large Right |
| 00840124502895 | L-Plate Compression 6 Hole Right |
| 00840124502888 | L-Plate Compression 6 Hole Right |
| 00840124502871 | L-Plate Compression 5 Hole Left |
| 00840124502864 | L-Plate Compression 5 Hole Right |
| 00840124502857 | L-Plate Compression 4 Hole left |
| 00840124502840 | L-Plate Compression 4 Hole Right |
| 00840124502833 | MTP Dorsal Plate Revision Right 10 ° |
| 00840124502826 | MTP Dorsal Plate Revision Left 10 ° |
| 00840124502819 | MTP Dorsal Plate Revision Neutral Right |
| 00840124502802 | MTP Dorsal Plate Revision Neutral Left |
| 00840124502796 | MTP Dorsal Plate Large Right 10 ° |
| 00840124502789 | MTP Dorsal Plate Large Neutral Right |
| 00840124502772 | MTP Dorsal Plate Large Left 10 ° |
| 00840124502765 | MTP Dorsal Plate Neutral Large Left |
| 00840124502758 | MTP Dorsal Plate Small Right 10 ° |
| 00840124502741 | MTP Dorsal Plate Small Right Neutral |