The following data is part of a premarket notification filed by Stabiliz Orthopaedics, Llc with the FDA for Stabiliz Fixation System - Spl Locking Screw.
| Device ID | K130731 |
| 510k Number | K130731 |
| Device Name: | STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW |
| Classification | Plate, Fixation, Bone |
| Applicant | STABILIZ ORTHOPAEDICS, LLC 665 STOCKTON DRIVE Exton, PA 19341 |
| Contact | Douglas L Cerynik, Md |
| Correspondent | Douglas L Cerynik, Md STABILIZ ORTHOPAEDICS, LLC 665 STOCKTON DRIVE Exton, PA 19341 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-18 |
| Decision Date | 2013-07-19 |
| Summary: | summary |