The following data is part of a premarket notification filed by Conformis, Inc with the FDA for Itotal Family Reusable Instrument Tray.
| Device ID | K170226 |
| 510k Number | K170226 |
| Device Name: | ITotal Family Reusable Instrument Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | CONFORMIS, INC 28 CROSBY DRIVE Bedford, MA 01730 |
| Contact | Emmanuel O. Nyakako |
| Correspondent | Emmaniel O. Nyakako CONFORMIS, INC 28 CROSBY DRIVE Bedford, MA 01730 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-25 |
| Decision Date | 2017-10-25 |