The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine 7d Navigation Instruments.
| Device ID | K222753 |
| 510k Number | K222753 |
| Device Name: | SeaSpine 7D Navigation Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsband, CA 92008 |
| Contact | Laeitia Cousin |
| Correspondent | Elena Marenny 7D Surgical ULC 60 Scarsdale Road, Unit 118 Toronto, CA M3B 2R7 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-12 |
| Decision Date | 2022-12-09 |