| Primary Device ID | M5289P15PB01A0 |
| NIH Device Record Key | 7e4a2f8f-db38-4042-b346-39fc5beea461 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Toe MotionTM |
| Version Model Number | 9P15-PB01-A |
| Catalog Number | 9P15-PB01-A |
| Company DUNS | 144666109 |
| Company Name | ARTHROSURFACE INCORPORATED |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M5289P15PB01A0 [Primary] |
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-04-21 |
| Device Publish Date | 2015-09-15 |
| M5289P15S180A0 | Fixation Component, DF-P |
| M5289P15PB02A0 | Modular Insert, 2.5mm Offset -02 (4.6mm thick) |
| M5289P15PB01A0 | Modular Insert, 2.5mm Offset -01 (3.6mm thick) |
| M5289P15PA02A0 | Modular Insert, 1.5mm Offset -02 (4.6mm thick) |
| M5289P15PA01A0 | Modular Insert, 1.5mm Offset -01 (3.6mm thick) |
| M5289P1501000 | Insert Delivery Tool, DF-P |