Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K222004
INTEGRATE -C Interbody Fusion System · Happe Spine · decided 2023-04-28 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| INTEGRATE-C | Trial - Large 20 x 15 x 11/12 mm, 10 deg | Happe Spine, LLC | LYQ | G2308HT1112L100 |
| INTEGRATE-C | Large, 20 x 15 x 7 mm , 10 deg | Happe Spine, LLC | ODP | G2308H2AF07L100 |
| INTEGRATE-C | Trial - Large 20 x 15 x 5/6 mm, 7 deg | Happe Spine, LLC | LYQ | G2308H1CT056L70 |
| INTEGRATE-C | Medium, 17 x 14 x 7 mm , 10 deg | Happe Spine, LLC | ODP | G2308H2AF07M100 |
| INTEGRATE-C | Medium, 17 x 14 x 9 mm ,7 deg | Happe Spine, LLC | ODP | G2308H2AF09M070 |
| INTEGRATE-C | Rasping Trial - Medium 17 x 14 x 5/6 mm, 10 deg | Happe Spine, LLC | LYQ | G2308H1CR56M100 |
| INTEGRATE-C | Trial - Medium 17 x 14 x 11/12 mm, 10 deg | Happe Spine, LLC | LYQ | G2308HT1112M100 |
| INTEGRATE-C | Small, 15 x 12 x 12 mm , 10 deg | Happe Spine, LLC | ODP | G2308H2AF12S100 |
| INTEGRATE-C | Trial - Large 20 x 15 x 11/12 mm, 7 deg | Happe Spine, LLC | LYQ | G2308H1CT012L70 |
| INTEGRATE-C | Trial - Large 20 x 15 x 9/10 mm, 10 deg | Happe Spine, LLC | LYQ | G2308HT0910L100 |
| INTEGRATE-C | Medium, 17 x 14 x 8 mm , 10 deg | Happe Spine, LLC | ODP | G2308H2AF08M100 |
| INTEGRATE-C | Small, 15 x 12 x 14 mm ,7 deg | Happe Spine, LLC | ODP | G2308H2AF14S070 |
| INTEGRATE-C | Large, 20 x 15 x 13 mm ,7 deg | Happe Spine, LLC | ODP | G2308H2AF13L070 |
| INTEGRATE-C | Trial - Large 20 x 15 x 13/14mm , 7 deg | Happe Spine, LLC | LYQ | G2308H1CT034L70 |
| INTEGRATE-C | Rasping Trial - Medium 17 x 14 x 5/6 mm, 7 deg | Happe Spine, LLC | LYQ | G2308H1CR056M70 |
| INTEGRATE-C | Trial - Medium 17 x 14 x 5/6 mm, 10 deg | Happe Spine, LLC | LYQ | G2308HT0506M100 |
| INTEGRATE-C | Medium, 17 x 14 x 10 mm ,7 deg | Happe Spine, LLC | ODP | G2308H2AF10M070 |
| INTEGRATE-C | Small, 15 x 12 x 14 mm , 10 deg | Happe Spine, LLC | ODP | G2308H2AF14S100 |
| INTEGRATE-C | Removal Tool | Happe Spine, LLC | LYQ | G2308H1CZ001390 |
| INTEGRATE-C | Large, 20 x 15 x 6 mm ,7 deg | Happe Spine, LLC | ODP | G2308H2AF06L070 |
| INTEGRATE-C | Trial - Large 20 x 15 x 13/14mm , 10 deg | Happe Spine, LLC | LYQ | G2308HT1314L100 |
| INTEGRATE-C | Large, 20 x 15 x 11 mm ,7 deg | Happe Spine, LLC | ODP | G2308H2AF11L070 |
| INTEGRATE-C | Small, 15 x 12 x 5 mm , 10 deg | Happe Spine, LLC | ODP | G2308H2AF05S100 |
| INTEGRATE-C | Medium, 17 x 14 x 11 mm ,7 deg | Happe Spine, LLC | ODP | G2308H2AF11M070 |
| INTEGRATE-C | Large, 20 x 15 x 12 mm ,7 deg | Happe Spine, LLC | ODP | G2308H2AF12L070 |