The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Paramount Anterior Cervical Cage System.
| Device ID | K173175 |
| 510k Number | K173175 |
| Device Name: | Paramount Anterior Cervical Cage System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | Spine Wave, Inc. 3 Enterprise Drive Suite 210 Shelton, CT 06484 |
| Contact | Yvonne Riley-poku |
| Correspondent | Yvonne Riley-poku Spine Wave, Inc. 3 Enterprise Drive Suite 210 Shelton, CT 06484 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840642124743 | K173175 | 000 |
| 10840642124927 | K173175 | 000 |
| 10840642124934 | K173175 | 000 |
| 10840642124941 | K173175 | 000 |
| 10840642124958 | K173175 | 000 |
| 10840642125009 | K173175 | 000 |
| 10840642125016 | K173175 | 000 |
| 10840642125023 | K173175 | 000 |
| 10840642125030 | K173175 | 000 |
| 10840642124910 | K173175 | 000 |
| 10840642124903 | K173175 | 000 |
| 10840642124897 | K173175 | 000 |
| 10840642124750 | K173175 | 000 |
| 10840642124767 | K173175 | 000 |
| 10840642124774 | K173175 | 000 |
| 10840642124781 | K173175 | 000 |
| 10840642124798 | K173175 | 000 |
| 10840642124866 | K173175 | 000 |
| 10840642124873 | K173175 | 000 |
| 10840642124880 | K173175 | 000 |
| 10840642125047 | K173175 | 000 |
| 10840642125054 | K173175 | 000 |
| 10840642125061 | K173175 | 000 |
| 10840642129335 | K173175 | 000 |
| 10840642129342 | K173175 | 000 |
| 10840642129359 | K173175 | 000 |
| 10840642129366 | K173175 | 000 |
| 10840642129373 | K173175 | 000 |
| 10840642129380 | K173175 | 000 |
| 10840642129397 | K173175 | 000 |
| 10840642129403 | K173175 | 000 |
| 10840642129328 | K173175 | 000 |
| 10840642149562 | K173175 | 000 |
| 10840642125153 | K173175 | 000 |
| 10840642125078 | K173175 | 000 |
| 10840642125085 | K173175 | 000 |
| 10840642125092 | K173175 | 000 |
| 10840642125108 | K173175 | 000 |
| 10840642125115 | K173175 | 000 |
| 10840642125122 | K173175 | 000 |
| 10840642125139 | K173175 | 000 |
| 10840642125146 | K173175 | 000 |
| 10840642129632 | K173175 | 000 |