The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Protex Stabilization System With Additional Componentes.
| Device ID | K052069 |
| 510k Number | K052069 |
| Device Name: | PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | GLOBUS MEDICAL INC. 303 SCHELL LN. Phoenixville, PA 19460 |
| Contact | Kelly J Baker |
| Correspondent | Kelly J Baker GLOBUS MEDICAL INC. 303 SCHELL LN. Phoenixville, PA 19460 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-01 |
| Decision Date | 2005-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095035056 | K052069 | 000 |
| 00889095034875 | K052069 | 000 |
| 00889095034868 | K052069 | 000 |
| 00889095034851 | K052069 | 000 |
| 00889095034844 | K052069 | 000 |
| 00889095034837 | K052069 | 000 |
| 00889095034820 | K052069 | 000 |
| 00889095034813 | K052069 | 000 |
| 00889095034806 | K052069 | 000 |
| 00889095034790 | K052069 | 000 |
| 00889095034783 | K052069 | 000 |
| 00889095034776 | K052069 | 000 |
| 00889095034769 | K052069 | 000 |
| 00889095034752 | K052069 | 000 |
| 00889095034745 | K052069 | 000 |
| 00889095034738 | K052069 | 000 |
| 00889095034882 | K052069 | 000 |
| 00889095034899 | K052069 | 000 |
| 00889095035049 | K052069 | 000 |
| 00889095035032 | K052069 | 000 |
| 00889095035025 | K052069 | 000 |
| 00889095035018 | K052069 | 000 |
| 00889095035001 | K052069 | 000 |
| 00889095034998 | K052069 | 000 |
| 00889095034981 | K052069 | 000 |
| 00889095034974 | K052069 | 000 |
| 00889095034967 | K052069 | 000 |
| 00889095034950 | K052069 | 000 |
| 00889095034943 | K052069 | 000 |
| 00889095034936 | K052069 | 000 |
| 00889095034929 | K052069 | 000 |
| 00889095034912 | K052069 | 000 |
| 00889095034905 | K052069 | 000 |
| 00889095034721 | K052069 | 000 |