The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine Ais-c Cervical Stand-alone System.
| Device ID | K181295 |
| 510k Number | K181295 |
| Device Name: | Genesys Spine AIS-C Cervical Stand-Alone System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | Genesys Spine 1250 Capital Of Texas Highway South Building 3 Suite 600 Austin, TX 78746 |
| Contact | Benjamin V. Keller |
| Correspondent | Benjamin Keller Genesys Spine 1250 Capital Of Texas Highway South Building 3 Suite 600 Austin, Tx 78746 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-16 |
| Decision Date | 2018-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M719G45130 | K181295 | 000 |
| M719G45000 | K181295 | 000 |
| M719G4500U0 | K181295 | 000 |
| M719G45010 | K181295 | 000 |
| M719G45020 | K181295 | 000 |
| M719G45030 | K181295 | 000 |
| M719G45040 | K181295 | 000 |
| M719G45050 | K181295 | 000 |
| M719G45060 | K181295 | 000 |
| M719G45070 | K181295 | 000 |
| M719G45080 | K181295 | 000 |
| M719GAC1101N0 | K181295 | 000 |
| M719GAC300120 | K181295 | 000 |
| M719GAC300110 | K181295 | 000 |
| M719GAC300100 | K181295 | 000 |
| M719G45140 | K181295 | 000 |
| M719G45150 | K181295 | 000 |
| M719G45160 | K181295 | 000 |
| M719G50140 | K181295 | 000 |
| M719G50150 | K181295 | 000 |
| M719GAC11100 | K181295 | 000 |
| M719GAC300050 | K181295 | 000 |
| M719GAC300060 | K181295 | 000 |
| M719GAC300070 | K181295 | 000 |
| M719GAC300080 | K181295 | 000 |
| M719GAC300090 | K181295 | 000 |
| M719GAC110TW10 | K181295 | 000 |
| M719GAC110TW20 | K181295 | 000 |
| M719GAC110TW30 | K181295 | 000 |
| M719GAC111S20 | K181295 | 000 |
| M719GAC111S30 | K181295 | 000 |
| M719GAC111S40 | K181295 | 000 |
| M719GAC111SN0 | K181295 | 000 |
| M719GAC11910 | K181295 | 000 |
| M719GAC11920 | K181295 | 000 |
| M719GAC11930 | K181295 | 000 |
| M719GAC11940 | K181295 | 000 |
| M719GAC119N0 | K181295 | 000 |
| M719GAC110T0 | K181295 | 000 |
| M719GAC1140 | K181295 | 000 |
| M719GAC111S10 | K181295 | 000 |
| M719GAC111N0 | K181295 | 000 |
| M719GAC111LN0 | K181295 | 000 |
| M719GAC110TW40 | K181295 | 000 |
| M719GAC110TWN0 | K181295 | 000 |
| M719GAC110W10 | K181295 | 000 |
| M719GAC110W20 | K181295 | 000 |
| M719GAC110W30 | K181295 | 000 |
| M719GAC110W40 | K181295 | 000 |
| M719GAC11140 | K181295 | 000 |
| M719GAC111L10 | K181295 | 000 |
| M719GAC111L20 | K181295 | 000 |
| M719GAC111L30 | K181295 | 000 |
| M719GAC111L40 | K181295 | 000 |
| M719GAC1200 | K181295 | 000 |