The following data is part of a premarket notification filed by Orthocrat, Ltd. with the FDA for Traumacad Version 2.0.
| Device ID | K073714 |
| 510k Number | K073714 |
| Device Name: | TRAUMACAD VERSION 2.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | ORTHOCRAT, LTD. 291 Hillside Avenue Somerset, MA 02726 |
| Contact | George J Hattub |
| Correspondent | George J Hattub ORTHOCRAT, LTD. 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-31 |
| Decision Date | 2008-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109941004 | K073714 | 000 |