The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Ellipse Occipito-cervico-thoracic Spinal System.
Device ID | K110963 |
510k Number | K110963 |
Device Name: | ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
Contact | Kelly J Baker, Ph.d |
Correspondent | Kelly J Baker, Ph.d GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon, PA 19403 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-06 |
Decision Date | 2011-05-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00849044036404 | K110963 | 000 |
00849044036268 | K110963 | 000 |
00849044036275 | K110963 | 000 |
00849044036282 | K110963 | 000 |
00849044036299 | K110963 | 000 |
00849044036305 | K110963 | 000 |
00849044036312 | K110963 | 000 |
00849044036329 | K110963 | 000 |
00849044036336 | K110963 | 000 |
00849044036343 | K110963 | 000 |
00849044036350 | K110963 | 000 |
00849044036367 | K110963 | 000 |
00849044036374 | K110963 | 000 |
00849044036381 | K110963 | 000 |
00849044036398 | K110963 | 000 |
00849044036251 | K110963 | 000 |