The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Hacancellous Peek-c Porous Ha Peek Cervical Ibf System.
| Device ID | K220875 |
| 510k Number | K220875 |
| Device Name: | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Innovasis, Inc. 614 E 3900 S Salt Lake City, UT 84107 |
| Contact | Marshall McCarty |
| Correspondent | Marshall McCarty Innovasis, Inc. 614 E 3900 S 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 | 2022-03-25 |
| Decision Date | 2022-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M711591315070 | K220875 | 000 |
| M711591417111 | K220875 | 000 |
| M711591517061 | K220875 | 000 |
| M711591517071 | K220875 | 000 |
| M711591517081 | K220875 | 000 |
| M711591517091 | K220875 | 000 |
| M711591517101 | K220875 | 000 |
| M711591517111 | K220875 | 000 |
| M711591517121 | K220875 | 000 |
| M711591618061 | K220875 | 000 |
| M711591618071 | K220875 | 000 |
| M711591618081 | K220875 | 000 |
| M711591417101 | K220875 | 000 |
| M711591417091 | K220875 | 000 |
| M711591417081 | K220875 | 000 |
| M711591315081 | K220875 | 000 |
| M711591315091 | K220875 | 000 |
| M711591315101 | K220875 | 000 |
| M711591315121 | K220875 | 000 |
| M711591416081 | K220875 | 000 |
| M711591416091 | K220875 | 000 |
| M711591416101 | K220875 | 000 |
| M711591416111 | K220875 | 000 |
| M711591416121 | K220875 | 000 |
| M711591417061 | K220875 | 000 |
| M711591417071 | K220875 | 000 |
| M711591618091 | K220875 | 000 |
| M711591618101 | K220875 | 000 |
| M711591214081 | K220875 | 000 |
| M711591214091 | K220875 | 000 |
| M711591214101 | K220875 | 000 |
| M711591214111 | K220875 | 000 |
| M711591214121 | K220875 | 000 |
| M711591215061 | K220875 | 000 |
| M711591215071 | K220875 | 000 |
| M711591215081 | K220875 | 000 |
| M711591215091 | K220875 | 000 |
| M711591215101 | K220875 | 000 |
| M711591215111 | K220875 | 000 |
| M711591214071 | K220875 | 000 |
| M711591214060 | K220875 | 000 |
| M711591619111 | K220875 | 000 |
| M711591618111 | K220875 | 000 |
| M711591618121 | K220875 | 000 |
| M711591619061 | K220875 | 000 |
| M711591315061 | K220875 | 000 |
| M711591315111 | K220875 | 000 |
| M711591416061 | K220875 | 000 |
| M711591416071 | K220875 | 000 |
| M711591619071 | K220875 | 000 |
| M711591619081 | K220875 | 000 |
| M711591619091 | K220875 | 000 |
| M711591619101 | K220875 | 000 |
| M711591215121 | K220875 | 000 |