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 |