The following data is part of a premarket notification filed by Medist International with the FDA for Single Size Tendon Spacer.
| Device ID | K000019 |
| 510k Number | K000019 |
| Device Name: | SINGLE SIZE TENDON SPACER |
| Classification | Prosthesis, Tendon, Passive |
| Applicant | MEDIST INTERNATIONAL 9160 HIGHWAY 64 SUITE 12 Lakeland, TN 38002 |
| Contact | Bernard F Grisoni |
| Correspondent | Bernard F Grisoni MEDIST INTERNATIONAL 9160 HIGHWAY 64 SUITE 12 Lakeland, TN 38002 |
| Product Code | HXA |
| CFR Regulation Number | 888.3025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-04 |
| Decision Date | 2000-03-29 |