| Primary Device ID | B046WZC26610 |
| NIH Device Record Key | 6b19cb03-cfb6-4b64-a6fc-891b484608bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Femoral Wedge |
| Version Model Number | 5-6 Posterior Thin |
| Catalog Number | WZ-C-2661 |
| Company DUNS | 169289308 |
| Company Name | SIGNAL MEDICAL CORPORATION |
| 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 | true |
| 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 |
| Phone | 810-364-7070 |
| vfowler@signalmd.com | |
| Phone | 810-364-7070 |
| vfowler@signalmd.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B046WZC26610 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-06-28 |
| B046WZC26660 | Femoral Wedge 7-8 Posterior Thick |
| B046WZC26650 | Femoral Wedge 7-8 Posterior Thin |
| B046WZC26640 | Femoral Wedge 7-8 Distal Full |
| B046WZC26630 | Femoral Wedge 7-8 Distal Half |
| B046WZC26620 | Femoral Wedge 5-6 Posterior Thick |
| B046WZC26610 | Femoral Wedge 5-6 Posterior Thin |
| B046WZC26600 | Femoral Wedge 5-6 Distal Full |
| B046WZC26590 | Femoral Wedge 5-6 Distal Half |
| B046WZC26580 | Femoral Wedge 3-4 Posterior Thick |
| B046WZC26570 | Femoral Wedge 3-4 Posterior Thin |
| B046WZC26560 | Femoral Wedge 3-4 Distal Full |
| B046WZC26550 | Femoral Wedge 3-4 Distal Half |