The following data is part of a premarket notification filed by Signal Medical Corp. with the FDA for Great Toe Implant.
| Device ID | K021063 |
| 510k Number | K021063 |
| Device Name: | GREAT TOE IMPLANT |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | SIGNAL MEDICAL CORP. 3777 LAPEER RD. 3-C Port Huron, MI 48060 |
| Contact | Louis A Serafin |
| Correspondent | Louis A Serafin SIGNAL MEDICAL CORP. 3777 LAPEER RD. 3-C Port Huron, MI 48060 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-02 |
| Decision Date | 2002-07-01 |
| Summary: | summary |