The following data is part of a premarket notification filed by Intelligent Implant Systems, Llc with the FDA for Marauder Cervical-thoracic Spinal Fixation System.
| Device ID | K132900 |
| 510k Number | K132900 |
| Device Name: | MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | INTELLIGENT IMPLANT SYSTEMS, LLC 3300 INTERNATIONAL AIRPORT DRIVE SUITE 1100 Charlotte, NC 28208 |
| Contact | Michael Nutt |
| Correspondent | Michael Nutt INTELLIGENT IMPLANT SYSTEMS, LLC 3300 INTERNATIONAL AIRPORT DRIVE SUITE 1100 Charlotte, NC 28208 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-16 |
| Decision Date | 2013-10-25 |
| Summary: | summary |