Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K161809
ShurFit CpTi-HA ACIF Interbody Fusion System · Precision Spine, Inc. · decided 2016-12-06 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ShurFit ACIF 2C | ACIF10-08P-2C | PRECISION SPINE, INC. | ODP | 00815362020753 |
| ShurFit ACIF 2C | ACIF05-05P-2C | PRECISION SPINE, INC. | ODP | 00815362020647 |
| ShurFit ACIF 2C | ACIF05-10P-2C | PRECISION SPINE, INC. | ODP | 00815362020692 |
| ShurFit ACIF 2C | 45-10-12P-2C | PRECISION SPINE, INC. | ODP | 00815362020951 |
| ShurFit ACIF 2C | ACIF05-08P-2C | PRECISION SPINE, INC. | ODP | 00815362020678 |
| ShurFit ACIF 2C | 45-10-07P-2C | PRECISION SPINE, INC. | ODP | 00815362020906 |
| ShurFit ACIF 2C | 45-10-05P-2C | PRECISION SPINE, INC. | ODP | 00815362020883 |
| ShurFit ACIF 2C | 45-10-11P-2C | PRECISION SPINE, INC. | ODP | 00815362020944 |
| ShurFit ACIF 2C | ACIF10-11P-2C | PRECISION SPINE, INC. | ODP | 00815362020784 |
| ShurFit ACIF 2C | 45-05-12P-2C | PRECISION SPINE, INC. | ODP | 00815362020876 |
| ShurFit ACIF 2C | 45-05-11P-2C | PRECISION SPINE, INC. | ODP | 00815362020869 |
| ShurFit ACIF 2C | ACIF05-11P-2C | PRECISION SPINE, INC. | ODP | 00815362020708 |
| ShurFit ACIF 2C | 62-SC-0102 | PRECISION SPINE, INC. | ODP | 00840019921473 |
| ShurFit ACIF 2C | 45-05-06P-2C | PRECISION SPINE, INC. | ODP | 00815362020814 |
| ShurFit ACIF 2C | ACIF10-06P-2C | PRECISION SPINE, INC. | ODP | 00815362020739 |
| ShurFit ACIF 2C | ACIF10-10P-2C | PRECISION SPINE, INC. | ODP | 00815362020777 |
| ShurFit ACIF 2C | 45-10-08P-2C | PRECISION SPINE, INC. | ODP | 00815362020913 |
| ShurFit ACIF 2C | 45-10-06P-2C | PRECISION SPINE, INC. | ODP | 00815362020890 |
| ShurFit ACIF 2C | 62-BK-0601 | PRECISION SPINE, INC. | ODP | 00840019932691 |
| ShurFit ACIF 2C | ACIF10-09P-2C | PRECISION SPINE, INC. | ODP | 00815362020760 |
| ShurFit ACIF 2C | 45-10-10P-2C | PRECISION SPINE, INC. | ODP | 00815362020937 |
| ShurFit ACIF 2C | 45-05-10P-2C | PRECISION SPINE, INC. | ODP | 00815362020852 |
| ShurFit ACIF 2C | 62-BK-0101 | PRECISION SPINE, INC. | ODP | 00840019932660 |
| ShurFit ACIF 2C | 45-05-08P-2C | PRECISION SPINE, INC. | ODP | 00815362020838 |
| ShurFit ACIF 2C | 62-PC-0003 | PRECISION SPINE, INC. | ODP | 00840019921459 |