The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Quartex Occipito-cervico-thoracic Spinal System, Globus Navigation Instruments.
Device ID | K211957 |
510k Number | K211957 |
Device Name: | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments |
Classification | Posterior Cervical Screw System |
Applicant | Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
Contact | Jennifer Antonacci |
Correspondent | Jennifer Antonacci Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
Product Code | NKG |
Subsequent Product Code | KWP |
Subsequent Product Code | OLO |
CFR Regulation Number | 888.3075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-06-24 |
Decision Date | 2021-08-18 |