The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Protex Ct Cervicothoracic Spinal System.
| Device ID | K081906 |
| 510k Number | K081906 |
| Device Name: | PROTEX CT CERVICOTHORACIC SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
| Contact | Kelly J Baker |
| Correspondent | Kelly J Baker GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon, PA 19403 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-03 |
| Decision Date | 2008-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095037562 | K081906 | 000 |
| 00889095037104 | K081906 | 000 |
| 00889095037111 | K081906 | 000 |
| 00889095037128 | K081906 | 000 |
| 00889095037197 | K081906 | 000 |
| 00889095037203 | K081906 | 000 |
| 00889095037210 | K081906 | 000 |
| 00889095037227 | K081906 | 000 |
| 00889095037234 | K081906 | 000 |
| 00889095037494 | K081906 | 000 |
| 00889095037098 | K081906 | 000 |