The following data is part of a premarket notification filed by Spinal Simplicity, Llc with the FDA for Spinous Process Fusion (spf) Plate.
| Device ID | K140046 |
| 510k Number | K140046 |
| Device Name: | SPINOUS PROCESS FUSION (SPF) PLATE |
| Classification | Spinous Process Plate |
| Applicant | SPINAL SIMPLICITY, LLC 1835 MARKET ST. 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan SPINAL SIMPLICITY, LLC 1835 MARKET ST. 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-08 |
| Decision Date | 2015-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M9431000040160 | K140046 | 000 |
| M9431000040140 | K140046 | 000 |
| M9431000040120 | K140046 | 000 |
| M9431000040100 | K140046 | 000 |
| M9431000040080 | K140046 | 000 |