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 |