The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Hedron Cervical Spacers, Hedron Lumbar Spacers, Sable Expandable Spacer, Excelsiusgps Instruments.
Device ID | K222270 |
510k Number | K222270 |
Device Name: | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
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 | ODP |
Subsequent Product Code | MAX |
Subsequent Product Code | OLO |
Subsequent Product Code | OVD |
Subsequent Product Code | OVE |
Subsequent Product Code | PHM |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-07-29 |
Decision Date | 2022-10-21 |