The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Cxha Peek Cervical Ibf System.
| Device ID | K181115 |
| 510k Number | K181115 |
| Device Name: | CxHA PEEK Cervical IBF System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107 |
| Contact | Marshall Mccarty |
| Correspondent | Marshall Mccarty Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-27 |
| Decision Date | 2018-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M711CH1215101 | K181115 | 000 |
| M711LS456240 | K181115 | 000 |
| M711LS456230 | K181115 | 000 |
| M711LS456220 | K181115 | 000 |
| M711LS456210 | K181115 | 000 |
| M711LS456200 | K181115 | 000 |
| M711LS456190 | K181115 | 000 |
| M711LS456180 | K181115 | 000 |
| M711LS456170 | K181115 | 000 |
| M711LS456160 | K181115 | 000 |
| M711CH1214061 | K181115 | 000 |
| M711CH1214071 | K181115 | 000 |
| M711CH1215091 | K181115 | 000 |
| M711CH1215081 | K181115 | 000 |
| M711CH1215071 | K181115 | 000 |
| M711CH1215061 | K181115 | 000 |
| M711CH1214121 | K181115 | 000 |
| M711CH1214111 | K181115 | 000 |
| M711CH1214101 | K181115 | 000 |
| M711CH1214091 | K181115 | 000 |
| M711CH1214081 | K181115 | 000 |
| M711LS456150 | K181115 | 000 |
| M711LS456140 | K181115 | 000 |
| M711LS456020 | K181115 | 000 |
| M711LS456010 | K181115 | 000 |
| M711LS456320 | K181115 | 000 |
| M711LS456310 | K181115 | 000 |
| M711LS456300 | K181115 | 000 |
| M711LS456290 | K181115 | 000 |
| M711LS456280 | K181115 | 000 |
| M711LS456270 | K181115 | 000 |
| M711LS456260 | K181115 | 000 |
| M711LS456030 | K181115 | 000 |
| M711LS456040 | K181115 | 000 |
| M711LS456130 | K181115 | 000 |
| M711LS456120 | K181115 | 000 |
| M711LS456110 | K181115 | 000 |
| M711LS456100 | K181115 | 000 |
| M711LS456090 | K181115 | 000 |
| M711LS456080 | K181115 | 000 |
| M711LS456070 | K181115 | 000 |
| M711LS456060 | K181115 | 000 |
| M711LS456050 | K181115 | 000 |
| M711LS456250 | K181115 | 000 |
| M711BTA1590 | K181115 | 000 |
| M711CH1618081 | K181115 | 000 |
| M711CH1618071 | K181115 | 000 |
| M711CH1618061 | K181115 | 000 |
| M711CH1517121 | K181115 | 000 |
| M711CH1517111 | K181115 | 000 |
| M711CH1517101 | K181115 | 000 |
| M711CH1517091 | K181115 | 000 |
| M711CH1517081 | K181115 | 000 |
| M711CH1517071 | K181115 | 000 |
| M711CH1618091 | K181115 | 000 |
| M711CH1618101 | K181115 | 000 |
| M711CH1619121 | K181115 | 000 |
| M711CH1619111 | K181115 | 000 |
| M711CH1619101 | K181115 | 000 |
| M711CH1619091 | K181115 | 000 |
| M711CH1619081 | K181115 | 000 |
| M711CH1619071 | K181115 | 000 |
| M711CH1619061 | K181115 | 000 |
| M711CH1618121 | K181115 | 000 |
| M711CH1618111 | K181115 | 000 |
| M711CH1517061 | K181115 | 000 |
| M711CH1417121 | K181115 | 000 |
| M711CH1416061 | K181115 | 000 |
| M711CH1315121 | K181115 | 000 |
| M711CH1315111 | K181115 | 000 |
| M711CH1315101 | K181115 | 000 |
| M711CH1315091 | K181115 | 000 |
| M711CH1315081 | K181115 | 000 |
| M711CH1315071 | K181115 | 000 |
| M711CH1315061 | K181115 | 000 |
| M711CH1215121 | K181115 | 000 |
| M711CH1416071 | K181115 | 000 |
| M711CH1416081 | K181115 | 000 |
| M711CH1417111 | K181115 | 000 |
| M711CH1417101 | K181115 | 000 |
| M711CH1417081 | K181115 | 000 |
| M711CH1417071 | K181115 | 000 |
| M711CH1417061 | K181115 | 000 |
| M711CH1416121 | K181115 | 000 |
| M711CH1416111 | K181115 | 000 |
| M711CH1416101 | K181115 | 000 |
| M711CH1416091 | K181115 | 000 |
| M711CH1215111 | K181115 | 000 |