The following data is part of a premarket notification filed by Surgical Theater, Llc with the FDA for Surgical Planner (srp).
| Device ID | K170793 |
| 510k Number | K170793 |
| Device Name: | SuRgical Planner (SRP) |
| Classification | System, Image Processing, Radiological |
| Applicant | Surgical Theater, LLC 781 Beta Drive Mayfield Village, OH 44143 |
| Contact | Kevin Murrock |
| Correspondent | Kevin Murrock Surgical Theater, LLC 781 Beta Drive 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 | 2017-03-16 |
| Decision Date | 2018-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863157000336 | K170793 | 000 |