The following data is part of a premarket notification filed by Intelligent Implant Systems, Llc with the FDA for Active Screw Bone Screw.
| Device ID | K121682 |
| 510k Number | K121682 |
| Device Name: | ACTIVE SCREW BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | INTELLIGENT IMPLANT SYSTEMS, LLC 3300 INTERNATIONAL AIRPORT DRIVE SUITE 1100 Charlotte, NC 28208 |
| Contact | Michael J Nutt |
| Correspondent | Michael J Nutt INTELLIGENT IMPLANT SYSTEMS, LLC 3300 INTERNATIONAL AIRPORT DRIVE SUITE 1100 Charlotte, NC 28208 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-07 |
| Decision Date | 2012-10-04 |
| Summary: | summary |