Primary Device ID | B0462201020040 |
NIH Device Record Key | 2efdf668-e06c-45ce-aa2a-46109f0b02c7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Symmetric TK Femoral Component |
Version Model Number | 4LT |
Catalog Number | 22-01-02004 |
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 | 8103647070 |
jgorney@signalmd.com | |
Phone | 8103647070 |
jgorney@signalmd.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B0462201020040 [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 | 2016-08-05 |
B046220102104 | 4RT Symmetric TK Femoral Component |
B0462201021050 | 5RT Symmetric TK Femoral Component |
B0462201020070 | 7LT Symmetric TK Femoral Component |
B0462201020060 | Symmetric TK Femoral Component 6LT |
B0462201020050 | 5LT Symmetric TK Femoral Component |
B0462201020040 | 4LT Symmetric TK Femoral Component |
B0462201021030 | 3RT Symmetric TK Femoral Component |
B0462201020030 | 3LT Symmetric TK Femoral Component |