The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Quintex Cervical Plating System.
| Device ID | K100243 |
| 510k Number | K100243 |
| Device Name: | QUINTEX CERVICAL PLATING SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Lisa Boyle |
| Correspondent | Lisa Boyle AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-27 |
| Decision Date | 2010-09-02 |
| Summary: | summary |