The following data is part of a premarket notification filed by Globus Medical, Inc. with the FDA for Modification To Beacon Stabilization System.
| Device ID | K092610 |
| 510k Number | K092610 |
| Device Name: | MODIFICATION TO BEACON STABILIZATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-25 |
| Decision Date | 2009-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849044024838 | K092610 | 000 |
| 00849044024821 | K092610 | 000 |
| 00849044024814 | K092610 | 000 |
| 00849044024807 | K092610 | 000 |
| 00849044005295 | K092610 | 000 |
| 00849044005288 | K092610 | 000 |
| 00849044005271 | K092610 | 000 |
| 00849044005264 | K092610 | 000 |