The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Great Toe Implant.
| Device ID | K920667 |
| 510k Number | K920667 |
| Device Name: | GREAT TOE IMPLANT |
| Classification | Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained |
| Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Contact | Randall Huebner |
| Correspondent | Randall Huebner ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Product Code | LZJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-13 |
| Decision Date | 1992-06-19 |