The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Truliant Porous Tibial Tray And Exactech Alteon Bone Screws.
| Device ID | K182346 |
| 510k Number | K182346 |
| Device Name: | TRULIANT Porous Tibial Tray And Exactech Alteon Bone Screws |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Exactech, Inc. 2320 N.W. 66th Court Gainesville, FL 32653 |
| Contact | Meredith May |
| Correspondent | Meredith Lee May Empirical Consulting LLC 4628 Northpark Dr Colorado Springs, CO 80918 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-28 |
| Decision Date | 2018-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862584083 | K182346 | 000 |
| 10885862591159 | K182346 | 000 |
| 10885862523747 | K182346 | 000 |
| 10885862532039 | K182346 | 000 |
| 10885862532022 | K182346 | 000 |
| 10885862532015 | K182346 | 000 |
| 10885862584229 | K182346 | 000 |