The following data is part of a premarket notification filed by Spinal Simplicity Llc with the FDA for Posterior Fusion Plate, Ha Posterior Fusion Plate.
| Device ID | K200066 |
| 510k Number | K200066 |
| Device Name: | Posterior Fusion Plate, HA Posterior Fusion Plate |
| Classification | Spinous Process Plate |
| Applicant | Spinal Simplicity LLC 6600 College Blvd, Ste 220 Overland Park, KS 66211 |
| Contact | Adam Rogers |
| Correspondent | Adam Rogers Spinal Simplicity LLC 6600 College Blvd, Ste 220 Overland Park, KS 66211 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-13 |
| Decision Date | 2020-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M943100005014 | K200066 | 000 |
| M943100001008 | K200066 | 000 |
| M943100001010 | K200066 | 000 |
| M943100001012 | K200066 | 000 |
| M943100001014 | K200066 | 000 |
| M943100001016 | K200066 | 000 |
| M943100005008 | K200066 | 000 |
| M943100005010 | K200066 | 000 |
| M943100005012 | K200066 | 000 |
| M943100005016 | K200066 | 000 |