The following data is part of a premarket notification filed by Spectrum Spine Ip Holdings, Llc with the FDA for Spectrum Spine Spinous Process Device.
| Device ID | K130066 |
| 510k Number | K130066 |
| Device Name: | SPECTRUM SPINE SPINOUS PROCESS DEVICE |
| Classification | Spinous Process Plate |
| Applicant | SPECTRUM SPINE IP HOLDINGS, LLC 13540 GUILD AVE Apple Valley, MN 55124 |
| Contact | Rich Jansen |
| Correspondent | Rich Jansen SPECTRUM SPINE IP HOLDINGS, LLC 13540 GUILD AVE Apple Valley, MN 55124 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-10 |
| Decision Date | 2013-11-12 |
| Summary: | summary |