The following data is part of a premarket notification filed by Sintea Plustek, Llc with the FDA for Spider System Kolibri Cement Needle.
| Device ID | K130402 |
| 510k Number | K130402 |
| Device Name: | SPIDER SYSTEM KOLIBRI CEMENT NEEDLE |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | SINTEA PLUSTEK, LLC 13540 GUILD AVE Apple Valley, MN 55124 |
| Contact | Rich Jansen |
| Correspondent | Rich Jansen SINTEA PLUSTEK, LLC 13540 GUILD AVE Apple Valley, MN 55124 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-19 |
| Decision Date | 2013-04-01 |
| Summary: | summary |