| Primary Device ID | 00889795153661 |
| NIH Device Record Key | 25fa0155-dadc-4942-859d-22e4bdb3a6a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Precision MIS Bunion System |
| Version Model Number | P27-200-1000 |
| Catalog Number | P27-200-1000 |
| Company DUNS | 042961576 |
| Company Name | Paragon 28, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 00889795133083 | Screw Caddy Lid |
| 00889795133076 | Screw Caddy Base |
| 00889795133069 | Instrument Tray 2 |
| 00889795133052 | Instrument Tray 1 |
| 00889795133045 | Case Base |
| 00889795133038 | Case Lid |
| 00889795133021 | Curved Elevator |
| 00889795133014 | Straight Elevator |
| 00889795133007 | K-wire Tube, Ø4.0 Screw |
| 00889795132994 | K-wire Tube, Ø3.5 Screw |
| 00889795132987 | K-wire Tube, Ø3.0 Screw |
| 00889795132970 | Drill Guide Tube, Medial Screw, 4.0 Drill |
| 00889795132963 | Drill Guide Tube, Medial Screw, 3.5 Drill |
| 00889795132956 | Drill Guide Tube, Medial Screw, 3.0 Drill |
| 00889795132949 | Drill Guide Tube, Lateral Screw, 4.0 Drill |
| 00889795132932 | Drill Guide Tube, Lateral Screw, 3.5 Drill |
| 00889795132925 | Drill Guide Tube, Lateral Screw, 3.0 Drill |
| 00889795132918 | Screw Tube, Lateral Screw, Common |
| 00889795132901 | Parallel K-Wire Guide, Handled, Ø3.5 and Ø4.0 Screws |
| 00889795132895 | Parallel K-Wire Guide, Handled, Ø3.0 Screw |
| 00889795132888 | Drill Guide/Soft Tissue Protector (double sided), Handled, Ø4.0 Screw |
| 00889795132871 | Drill Guide/Soft Tissue Protector (double sided), Handled, Ø3.5 Screw |
| 00889795132864 | Drill Guide/Soft Tissue Protector (double sided), Handled, Ø3.0 Screw |
| 00889795132857 | Cleaning wire |
| 00889795132840 | Reduction Wire |
| 00889795132833 | Freer Elevator |
| 00889795132826 | Countersink, Ø4.0 Screw |
| 00889795132819 | Countersink, Ø3.5 Screw |
| 00889795132802 | Countersink, Ø3.0 Screw |
| 00889795132796 | Angel Wing |
| 00889795132789 | Outrigger, Left |
| 00889795132772 | Outrigger, Right |
| 00889795132765 | Depth Gauge, Common |
| 00889795132758 | Sterilization Container, K-wire, Outrigger Fixation |
| 00889795132741 | Sterilization Container for Ø1.7 x 230mm K-wire |
| 00889795132734 | Sterilization Container for Ø1.6 x 230mm K-wire |
| 00889795132727 | Sterilization Container for Ø1.2 x 230mm K-wire |
| 00889795132710 | Ø1.7 x 230mm Smooth K-wire for Ø4.0 Screw |
| 00889795132703 | Ø1.6 x 230mm Smooth K-wire for Ø3.5 Screw |
| 00889795132697 | Ø1.2 x 230mm Smooth K-wire for Ø3.0 Screw |
| 00889795132680 | K-wire, 2.0mm x 100mm |
| 00889795132604 | Ø3.5 Driver, Cannulated Long |
| 00889795132598 | Ø3.0 Driver, Cannulated Long |
| 00889795132581 | Ø3.0mm Cannulated Drill for Ø4.0 Screw, Short |
| 00889795132574 | Ø2.7mm Cannulated Drill for Ø3.5 Screw, Short |
| 00889795132567 | Ø2.4mm Cannulated Drill for Ø3.0 Screw, Short |
| 00889795132550 | Ø2.4mm Cannulated Drill for Ø3.0 Screw, Long |
| 00889795132222 | Precision MIS Screw, Cannulated, Ø4.0 x 70mm |
| 00889795132215 | Precision MIS Screw, Cannulated, Ø4.0 x 68mm |
| 00889795132208 | Precision MIS Screw, Cannulated, Ø4.0 x 66mm |