The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Koenig Total Toe Implant.
| Device ID | K884561 |
| 510k Number | K884561 |
| Device Name: | KOENIG TOTAL TOE IMPLANT |
| Classification | Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained |
| Applicant | DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Contact | Bailey Lipscomb |
| Correspondent | Bailey Lipscomb DOW CORNING WRIGHT P.O. BOX 100 Arlington, TN 38002 |
| Product Code | LZJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-31 |
| Decision Date | 1989-01-24 |