The following data is part of a premarket notification filed by Link America, Inc. with the FDA for Ellis External Mini-fixator System.
| Device ID | K964458 |
| 510k Number | K964458 |
| Device Name: | ELLIS EXTERNAL MINI-FIXATOR SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | LINK AMERICA, INC. 3700 SOUTH TAMIAMI TRAIL Sarasota, FL 34239 |
| Contact | Douglas W Stuart |
| Correspondent | Douglas W Stuart LINK AMERICA, INC. 3700 SOUTH TAMIAMI TRAIL Sarasota, FL 34239 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-07 |
| Decision Date | 1996-12-09 |