The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Sable Expandable Spacer.
| Device ID | K192115 |
| 510k Number | K192115 |
| Device Name: | SABLE Expandable Spacer |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Contact | Kelly J. Baker |
| Correspondent | Kelly J. Baker Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-06 |
| Decision Date | 2020-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889095966183 | K192115 | 000 |
| 00193982003616 | K192115 | 000 |
| 00193982003593 | K192115 | 000 |
| 00193982003586 | K192115 | 000 |
| 00193982003579 | K192115 | 000 |
| 00193982003562 | K192115 | 000 |
| 00193982003531 | K192115 | 000 |
| 00193982003524 | K192115 | 000 |
| 00889095965780 | K192115 | 000 |
| 00889095965766 | K192115 | 000 |
| 00889095965742 | K192115 | 000 |
| 00889095965728 | K192115 | 000 |
| 00889095965704 | K192115 | 000 |
| 00889095965841 | K192115 | 000 |
| 00889095965865 | K192115 | 000 |
| 00889095965889 | K192115 | 000 |
| 00889095966169 | K192115 | 000 |
| 00889095966145 | K192115 | 000 |
| 00889095966121 | K192115 | 000 |
| 00889095966107 | K192115 | 000 |
| 00889095966084 | K192115 | 000 |
| 00889095966060 | K192115 | 000 |
| 00889095966046 | K192115 | 000 |
| 00889095966022 | K192115 | 000 |
| 00889095966008 | K192115 | 000 |
| 00889095965940 | K192115 | 000 |
| 00889095965926 | K192115 | 000 |
| 00889095965902 | K192115 | 000 |
| 00889095965681 | K192115 | 000 |