The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine Binary Lumbar Plate System.
| Device ID | K173885 |
| 510k Number | K173885 |
| Device Name: | Genesys Spine Binary Lumbar Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Genesys Spine 1250 South Capital Of Texas Highway, Building 3 Suite 600 Austin, TX 78746 |
| Contact | Brian J. Bergeron |
| Correspondent | William W Sowers Genesys Spine 1250 South Capital Of Texas Highway, Building 3 Suite 600 Austin, TX 78746 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-21 |
| Decision Date | 2018-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M719GLP10101240 | K173885 | 000 |
| M719GLPV55200 | K173885 | 000 |
| M719GLPV55240 | K173885 | 000 |
| M719GLPV55280 | K173885 | 000 |
| M719GLPV55320 | K173885 | 000 |
| M719G100200 | K173885 | 000 |
| M719G100210 | K173885 | 000 |
| M719GLP100000150 | K173885 | 000 |
| M719GLP100000170 | K173885 | 000 |
| M719GLP100000190 | K173885 | 000 |
| M719GLP100000210 | K173885 | 000 |
| M719GLP1630 | K173885 | 000 |
| M719GLP1620 | K173885 | 000 |
| M719GLP10101280 | K173885 | 000 |
| M719GLP10101320 | K173885 | 000 |
| M719GLP10155210 | K173885 | 000 |
| M719GLP10155240 | K173885 | 000 |
| M719GLP10155280 | K173885 | 000 |
| M719GLP10155320 | K173885 | 000 |
| M719GLP15420 | K173885 | 000 |
| M719GLP1590 | K173885 | 000 |
| M719GLP1600 | K173885 | 000 |
| M719GLP1610 | K173885 | 000 |
| M719GLP100000230 | K173885 | 000 |
| M719GLP100000250 | K173885 | 000 |
| M719GLP15220 | K173885 | 000 |
| M719GLP111100 | K173885 | 000 |
| M719GLP111110 | K173885 | 000 |
| M719GLP111120 | K173885 | 000 |
| M719GLP111130 | K173885 | 000 |
| M719GLP111140 | K173885 | 000 |
| M719GLP111150 | K173885 | 000 |
| M719GLP111160 | K173885 | 000 |
| M719GLP111170 | K173885 | 000 |
| M719GLP111180 | K173885 | 000 |
| M719GLP111190 | K173885 | 000 |
| M719GLP111090 | K173885 | 000 |
| M719GLP111080 | K173885 | 000 |
| M719GLP15250 | K173885 | 000 |
| M719GLP1530 | K173885 | 000 |
| M719GLP15410 | K173885 | 000 |
| M719GLP1550 | K173885 | 000 |
| M719GLP1560 | K173885 | 000 |
| M719GLP1570 | K173885 | 000 |
| M719GLP1580 | K173885 | 000 |
| M719GLP111050 | K173885 | 000 |
| M719GLP111060 | K173885 | 000 |
| M719GLP111070 | K173885 | 000 |
| M719GLP111200 | K173885 | 000 |