The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine 3dp Lumbar Interbody System.
| Device ID | K220096 |
| 510k Number | K220096 |
| Device Name: | Genesys Spine 3DP Lumbar Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Genesys Spine 1250 South Capital Of Texas Highway, Building 3 Suite 600 Austin, TX 78746 |
| Contact | Chloe Lance |
| Correspondent | Chloe Lance Genesys Spine 1250 South Capital Of Texas Highway, Building 3 Suite 600 Austin, TX 78746 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-12 |
| Decision Date | 2022-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M719GP3D0732C0 | K220096 | 000 |
| M719GP3D0828C0 | K220096 | 000 |
| M719GP3D08340 | K220096 | 000 |
| M719GP3D08360 | K220096 | 000 |
| M719GP3D0928C0 | K220096 | 000 |
| M719GP3D09340 | K220096 | 000 |
| M719GP3D09360 | K220096 | 000 |
| M719GP3D1028C0 | K220096 | 000 |
| M719GP3D10340 | K220096 | 000 |
| M719GP3D10360 | K220096 | 000 |
| M719GP3D1128C0 | K220096 | 000 |
| M719GP3D11340 | K220096 | 000 |
| M719GP3D11360 | K220096 | 000 |
| M719GP3D1228C0 | K220096 | 000 |
| M719GP3D12340 | K220096 | 000 |
| M719GP3D12360 | K220096 | 000 |
| M719GP3D1328C0 | K220096 | 000 |
| M719GP3D07360 | K220096 | 000 |
| M719GP3D07340 | K220096 | 000 |
| M719GP3D0830C0 | K220096 | 000 |
| M719GP3D0832C0 | K220096 | 000 |
| M719GP3D0930C0 | K220096 | 000 |
| M719GP3D0932C0 | K220096 | 000 |
| M719GP3D1030C0 | K220096 | 000 |
| M719GP3D1032C0 | K220096 | 000 |
| M719GP3D1130C0 | K220096 | 000 |
| M719GP3D1132C0 | K220096 | 000 |
| M719GP3D1230C0 | K220096 | 000 |
| M719GP3D1330C0 | K220096 | 000 |
| M719GP3D1430C0 | K220096 | 000 |
| M719GP3D1530C0 | K220096 | 000 |
| M719GP3D0730C0 | K220096 | 000 |
| M719GP3D06340 | K220096 | 000 |
| M719GP3D06360 | K220096 | 000 |
| M719GP3D0728C0 | K220096 | 000 |
| M719GP3D13340 | K220096 | 000 |
| M719GP3D13360 | K220096 | 000 |
| M719GP3D1428C0 | K220096 | 000 |
| M719GP3D11320 | K220096 | 000 |
| M719GP3D12280 | K220096 | 000 |
| M719GP3D12300 | K220096 | 000 |
| M719GP3D12320 | K220096 | 000 |
| M719GP3D13280 | K220096 | 000 |
| M719GP3D13300 | K220096 | 000 |
| M719GP3D13320 | K220096 | 000 |
| M719GP3D14280 | K220096 | 000 |
| M719GP3D14300 | K220096 | 000 |
| M719GP3D14320 | K220096 | 000 |
| M719GP3D15280 | K220096 | 000 |
| M719GP3D15300 | K220096 | 000 |
| M719GP3D08280 | K220096 | 000 |
| M719GP3D09280 | K220096 | 000 |
| M719GP3D10280 | K220096 | 000 |
| M719GP3D06280 | K220096 | 000 |
| M719GP3D11300 | K220096 | 000 |
| M719GP3D11280 | K220096 | 000 |
| M719GP3D14340 | K220096 | 000 |
| M719GP3D14360 | K220096 | 000 |
| M719GP3D1528C0 | K220096 | 000 |
| M719GP3D15320 | K220096 | 000 |
| M719GP3D15340 | K220096 | 000 |
| M719GP3D15360 | K220096 | 000 |
| M719GP3D06300 | K220096 | 000 |
| M719GP3D06320 | K220096 | 000 |
| M719GP3D07300 | K220096 | 000 |
| M719GP3D07320 | K220096 | 000 |
| M719GP3D08300 | K220096 | 000 |
| M719GP3D08320 | K220096 | 000 |
| M719GP3D09300 | K220096 | 000 |
| M719GP3D09320 | K220096 | 000 |
| M719GP3D10300 | K220096 | 000 |
| M719GP3D10320 | K220096 | 000 |
| M719GP3D07280 | K220096 | 000 |