| Primary Device ID | 00889795146564 |
| NIH Device Record Key | 095b3c3b-4a31-4feb-8729-72ea3670de59 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Special Instrument |
| Version Model Number | SP27-102-1000 |
| Catalog Number | SP27-102-1000 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889795146564 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-04 |
| Device Publish Date | 2025-03-27 |
| 00889795016447 - Monster Screw System | 2025-04-22 Monster BITE, Driver, AO |
| 00889795017376 - Gorilla Plating System | 2025-04-22 BOW & Arrow Sizing Tool, Base & Cotton Small |
| 00889795017567 - Gorilla Plating System | 2025-04-22 Locking Drill Guide |
| 00889795017574 - Gorilla Plating System | 2025-04-22 Drill Guide, Non-Locking / Off-Axis Cone |
| 00889795017581 - Gorilla Plating System | 2025-04-22 Compression Slot Drill Guide |
| 00889795017598 - Gorilla Plating System | 2025-04-22 Inserter, Calcaneal Slide Plate |
| 00889795017604 - Gorilla Plating System | 2025-04-22 Pencil Inserter |
| 00889795017611 - Gorilla Plating System | 2025-04-22 Threaded Plate Bending Bar |