SURGICAL NAVIGATION ADVANCED PLATFORM
System, Image Processing, Radiological
SURGICAL THEATER, LLC
The following data is part of a premarket notification filed by Surgical Theater, Llc with the FDA for Surgical Navigation Advanced Platform.
Pre-market Notification Details
| Device ID | K140819 |
| 510k Number | K140819 |
| Device Name: | SURGICAL NAVIGATION ADVANCED PLATFORM |
| Classification | System, Image Processing, Radiological |
| Applicant | SURGICAL THEATER, LLC 781 BETA DR. Mayfield Village, OH 44143 |
| Contact | Mordechai Avisar |
| Correspondent | Mordechai Avisar SURGICAL THEATER, LLC 781 BETA DR. Mayfield Village, OH 44143 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-01 |
| Decision Date | 2014-06-27 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863157000305 | K140819 | 000 |
Trademark Results [SURGICAL NAVIGATION ADVANCED PLATFORM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGICAL NAVIGATION ADVANCED PLATFORM 86366919 4787608 Live/Registered |
Surgical Theater, LLC 2014-08-14 |
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