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 |