The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Shoreline Threaded Truprofile® Plate.
| Device ID | K211903 |
| 510k Number | K211903 |
| Device Name: | Shoreline Threaded TruProfile® Plate |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Contact | Kavita Chandrashekar |
| Correspondent | Kavita Chandrashekar SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-21 |
| Decision Date | 2021-08-30 |
| Summary: | summary |