The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Gts Great Toe System - (metatarsal Component With Porous Coating).
| Device ID | K950864 |
| 510k Number | K950864 |
| Device Name: | GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) |
| Classification | Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained |
| Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Contact | Shari L Jeffers |
| Correspondent | Shari L Jeffers 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 | 1995-02-27 |
| Decision Date | 1995-07-31 |