The following data is part of a premarket notification filed by Nemaris Inc with the FDA for Surgimap (tm) Spine.
| Device ID | K111019 |
| 510k Number | K111019 |
| Device Name: | SURGIMAP (TM) SPINE |
| Classification | System, Image Processing, Radiological |
| Applicant | NEMARIS INC 1425 K STREET N.W. 11TH FLOOR Washington, DC 20005 |
| Contact | Keith A Barritt |
| Correspondent | Keith A Barritt NEMARIS INC 1425 K STREET N.W. 11TH FLOOR Washington, DC 20005 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-12 |
| Decision Date | 2011-09-30 |
| Summary: | summary |