Company ยท US
Signal Medical Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2021. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 3 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 3 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | 1 |
| HTY | Pin, Fixation, Smooth | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 10, 2021 | K203779 | Symmetric Total Knee System Signal Medical Corporation | MBH |
| Mar 7, 2011 | K100370 | SYMMETRIC TOTAL KNEE AGUMENTS Signal Medical Corp. | JWH |
| Jul 3, 2008 | K080199 | SYMMETRIC TOTAL KNEE SYSTEM Signal Medical Corporation | JWH |
| Mar 24, 2008 | K073674 | BONE FIXATION WIRE (KIRSCHNER WIRE) Signal Medical Corp. | HTY |
| Mar 22, 2006 | K051510 | SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM Signal Medical Corp. | MBH |
| Feb 11, 2005 | K043289 | E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT Signal Medical Corp. | KTT |
| Oct 4, 2002 | K022382 | RHS ACETABULAR COMPONENT Signal Medical Corp. | LPH |
| Jul 1, 2002 | K021063 | GREAT TOE IMPLANT Signal Medical Corp. | KWD |
| Jun 25, 1998 | K981302 | SMC 28MM CERAMIC FEMORAL HEADS Signal Medical Corp. | LZO |
| Dec 4, 1997 | K971681 | SMC FEMORAL HIP COMPONENT Signal Medical Corp. | JDI |
| Oct 24, 1997 | K971018 | SMC ACETABULAR COMPONENT Signal Medical Corp. | LPH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2017 | Signal Medical Corporation Soft Face "No Bounce" Mallet
Model/Catalog: BIO-1-1090 Terminated |
GFJ | None listed |
| Oct 22, 2014 | Signal Medical Corporation Symmetric Total Knee Femoral Components
Product Usage:
Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replaceme Terminated |
JWH | K080199 |
| Oct 22, 2014 | Signal Medical Corporation Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20.
Device is intended for use with Whiteside Biomechanics, Inc./ Terminated |
LPH | K955271 |