The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Waveform™ A Interbody System.
| Device ID | K210583 |
| 510k Number | K210583 |
| Device Name: | SeaSpine WaveForm™ A Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Contact | Aly Alvarez |
| Correspondent | Alicia Mcarthur SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-26 |
| Decision Date | 2021-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981263676 | K210583 | 000 |