The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Unify(r) Dynamic Anterior Cervical Plate System.
| Device ID | K133567 |
| 510k Number | K133567 |
| Device Name: | UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Contact | Christina Kichula |
| Correspondent | Christina Kichula GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-20 |
| Decision Date | 2014-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095167023 | K133567 | 000 |
| 00889095166422 | K133567 | 000 |
| 00889095166446 | K133567 | 000 |
| 00889095166460 | K133567 | 000 |
| 00889095166477 | K133567 | 000 |
| 00889095166491 | K133567 | 000 |
| 00889095166514 | K133567 | 000 |
| 00889095166538 | K133567 | 000 |
| 00889095166545 | K133567 | 000 |
| 00889095166408 | K133567 | 000 |
| 00889095165913 | K133567 | 000 |
| 00889095165784 | K133567 | 000 |
| 00889095165807 | K133567 | 000 |
| 00889095165821 | K133567 | 000 |
| 00889095165838 | K133567 | 000 |
| 00889095165852 | K133567 | 000 |
| 00889095165876 | K133567 | 000 |
| 00889095165890 | K133567 | 000 |
| 00889095165906 | K133567 | 000 |
| 00889095166552 | K133567 | 000 |
| 00889095166682 | K133567 | 000 |
| 00889095166880 | K133567 | 000 |
| 00889095166897 | K133567 | 000 |
| 00889095166903 | K133567 | 000 |
| 00889095166941 | K133567 | 000 |
| 00889095166965 | K133567 | 000 |
| 00889095166989 | K133567 | 000 |
| 00889095167009 | K133567 | 000 |
| 00889095167016 | K133567 | 000 |
| 00889095166866 | K133567 | 000 |
| 00889095166842 | K133567 | 000 |
| 00889095166705 | K133567 | 000 |
| 00889095166729 | K133567 | 000 |
| 00889095166743 | K133567 | 000 |
| 00889095166750 | K133567 | 000 |
| 00889095166774 | K133567 | 000 |
| 00889095166798 | K133567 | 000 |
| 00889095166811 | K133567 | 000 |
| 00889095166828 | K133567 | 000 |
| 00889095165760 | K133567 | 000 |