The following data is part of a premarket notification filed by Precision Spine, Inc. with the FDA for Shurfit Cpti-ha Acif Interbody Fusion System.
| Device ID | K161809 |
| 510k Number | K161809 |
| Device Name: | ShurFit CpTi-HA ACIF Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Precision Spine, Inc. 2050 Executive Drive Pearl, MS 39208 |
| Contact | Michael C. Dawson |
| Correspondent | Michael C. Dawson Precision Spine, Inc. 2050 Executive Drive Pearl, MS 39208 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-01 |
| Decision Date | 2016-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840019932660 | K161809 | 000 |
| 00815362020715 | K161809 | 000 |
| 00815362020722 | K161809 | 000 |
| 00815362020739 | K161809 | 000 |
| 00815362020746 | K161809 | 000 |
| 00815362020753 | K161809 | 000 |
| 00815362020760 | K161809 | 000 |
| 00815362020777 | K161809 | 000 |
| 00815362020784 | K161809 | 000 |
| 00815362020708 | K161809 | 000 |
| 00815362020692 | K161809 | 000 |
| 00840019932677 | K161809 | 000 |
| 00840019932684 | K161809 | 000 |
| 00840019932691 | K161809 | 000 |
| 00840019932707 | K161809 | 000 |
| 00815362020654 | K161809 | 000 |
| 00815362020661 | K161809 | 000 |
| 00815362020678 | K161809 | 000 |
| 00815362020685 | K161809 | 000 |
| 00815362020791 | K161809 | 000 |
| 00815362020807 | K161809 | 000 |
| 00815362020814 | K161809 | 000 |
| 00815362020920 | K161809 | 000 |
| 00815362020937 | K161809 | 000 |
| 00815362020944 | K161809 | 000 |
| 00815362020951 | K161809 | 000 |
| 00815362020647 | K161809 | 000 |
| 00840019921459 | K161809 | 000 |
| 00840019921466 | K161809 | 000 |
| 00840019921473 | K161809 | 000 |
| 00815362020913 | K161809 | 000 |
| 00815362020906 | K161809 | 000 |
| 00815362020821 | K161809 | 000 |
| 00815362020838 | K161809 | 000 |
| 00815362020845 | K161809 | 000 |
| 00815362020852 | K161809 | 000 |
| 00815362020869 | K161809 | 000 |
| 00815362020876 | K161809 | 000 |
| 00815362020883 | K161809 | 000 |
| 00815362020890 | K161809 | 000 |
| 00840019921480 | K161809 | 000 |