The following data is part of a premarket notification filed by Surgical Theater, Inc. with the FDA for Spinear Snap.
| Device ID | K213034 |
| 510k Number | K213034 |
| Device Name: | SpineAR SNAP |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Surgical Theater, Inc. 30559 Pinetree Road, Suite 206 Pepper Pike, OH 44124 |
| Contact | Kevin Murrock |
| Correspondent | Kevin Murrock Surgical Theater, Inc. 30559 Pinetree Road, Suite 206 Pepper Pike, OH 44124 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-21 |
| Decision Date | 2022-09-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003884126 | K213034 | 000 |