The following data is part of a premarket notification filed by Surgical Theater, Llc with the FDA for Surgical Navigation Advanced Platform (snap).
| Device ID | K160584 |
| 510k Number | K160584 |
| Device Name: | Surgical Navigation Advanced Platform (SNAP) |
| Classification | System, Image Processing, Radiological |
| Applicant | SURGICAL THEATER, LLC 781 BETA DR. Mayfield Village, OH 44143 |
| Contact | Kevin Murrock |
| Correspondent | Kevin Murrock 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 | 2016-03-01 |
| Decision Date | 2016-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863157000374 | K160584 | 000 |
| 00863157000367 | K160584 | 000 |
| 00863157000329 | K160584 | 000 |
| 00863157000312 | K160584 | 000 |
| 00860003884102 | K160584 | 000 |
| 00863157000305 | K160584 | 000 |