The following data is part of a premarket notification filed by Spinenet Llc with the FDA for Spinenet Ssp System.
| Device ID | K200170 |
| 510k Number | K200170 |
| Device Name: | SpineNet SSP System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SpineNet LLC 1300 Minnesota Ave., Suite 200 Winter Park, FL 32789 |
| Contact | King Floyd |
| Correspondent | Karen E Warden BackRoads Consulting PO Box 566 Chesterland, OH 44026 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-23 |
| Decision Date | 2020-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B047FB46140 | K200170 | 000 |
| B04710603120 | K200170 | 000 |
| B047106020 | K200170 | 000 |
| B047106120 | K200170 | 000 |
| B047106110 | K200170 | 000 |
| B047106100 | K200170 | 000 |
| B047106080 | K200170 | 000 |
| B047106070 | K200170 | 000 |
| B047106060 | K200170 | 000 |
| B047106040 | K200170 | 000 |
| B04710603140 | K200170 | 000 |
| B04710603160 | K200170 | 000 |
| B04710603180 | K200170 | 000 |
| B047FB46120 | K200170 | 000 |
| B047FB42140 | K200170 | 000 |
| B047FB42120 | K200170 | 000 |
| B047248350 | K200170 | 000 |
| B047245320 | K200170 | 000 |
| B047242290 | K200170 | 000 |
| B047126130 | K200170 | 000 |
| B047124110 | K200170 | 000 |
| B047106090 | K200170 | 000 |
| B047106010 | K200170 | 000 |