The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Waveform, C Interbody System.
| Device ID | K213359 |
| 510k Number | K213359 |
| Device Name: | SeaSpine WaveForm, C Interbody System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Contact | Hong Phan |
| Correspondent | Aly Alvarez SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-12 |
| Decision Date | 2021-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981281021 | K213359 | 000 |
| 10889981280901 | K213359 | 000 |
| 10889981280895 | K213359 | 000 |
| 10889981280888 | K213359 | 000 |
| 10889981280871 | K213359 | 000 |
| 10889981280864 | K213359 | 000 |
| 10889981280857 | K213359 | 000 |
| 10889981280840 | K213359 | 000 |
| 10889981280833 | K213359 | 000 |
| 10889981280918 | K213359 | 000 |
| 10889981280925 | K213359 | 000 |
| 10889981280932 | K213359 | 000 |
| 10889981281014 | K213359 | 000 |
| 10889981281007 | K213359 | 000 |
| 10889981280994 | K213359 | 000 |
| 10889981280987 | K213359 | 000 |
| 10889981280970 | K213359 | 000 |
| 10889981280963 | K213359 | 000 |
| 10889981280956 | K213359 | 000 |
| 10889981280949 | K213359 | 000 |
| 10889981280826 | K213359 | 000 |