| Primary Device ID | 00850011453384 |
| NIH Device Record Key | 2d4fed99-235f-4bf4-b4df-ec57227986f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REMEDY Poly+Plus Tibial Spacer |
| Version Model Number | RPPLG17 |
| Catalog Number | RPPLG17 |
| Company DUNS | 079596704 |
| Company Name | OSTEOREMEDIES, LLC |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850011453384 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-24 |
| Device Publish Date | 2025-12-16 |
| 00850011453452 | Remedy POLY+PLUS Tibia Case Base |
| 00850011453445 | REMEDY® POLY+PLUS Tibial Trial LG 17 mm |
| 00850011453438 | REMEDY® POLY+PLUS Tibial Trial LG 13 mm |
| 00850011453421 | REMEDY® POLY+PLUS Tibial Trial MD 17 mm |
| 00850011453414 | REMEDY® POLY+PLUS Tibial Trial MD 13 mm |
| 00850011453407 | REMEDY® POLY+PLUS Tibial Trial SM 17 mm |
| 00850011453391 | REMEDY® POLY+PLUS Tibial Trial SM 13 mm |
| 00850011453384 | REMEDY® POLY+PLUS Tibial Comp. LG 17mm |
| 00850011453377 | REMEDY® POLY+PLUS Tibial Comp. LG 13mm |
| 00850011453360 | REMEDY® POLY+PLUS Tibial Comp. MD 17mm |
| 00850011453353 | REMEDY® POLY+PLUS Tibial Comp. MD 13mm |
| 00850011453346 | REMEDY® POLY+PLUS Tibial Comp. SM 17mm |
| 00850011453339 | REMEDY® POLY+PLUS Tibial Comp. SM 13mm |