The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Cocr Rods.
| Device ID | K100788 |
| 510k Number | K100788 |
| Device Name: | COCR RODS |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Kelly Baker |
| Correspondent | Kelly Baker GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. 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 | 2010-03-22 |
| Decision Date | 2010-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849044066050 | K100788 | 000 |
| 00849044056228 | K100788 | 000 |
| 00849044056235 | K100788 | 000 |
| 00849044056242 | K100788 | 000 |
| 00849044056259 | K100788 | 000 |
| 00849044066012 | K100788 | 000 |
| 00849044066029 | K100788 | 000 |
| 00849044066036 | K100788 | 000 |
| 00849044066043 | K100788 | 000 |
| 00849044056211 | K100788 | 000 |