The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Navigation System.
| Device ID | K172517 |
| 510k Number | K172517 |
| Device Name: | SeaSpine Navigation System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Contact | Gina Flores |
| Correspondent | Gina Flores SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-21 |
| Decision Date | 2018-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981239602 | K172517 | 000 |
| 10889981293437 | K172517 | 000 |
| 10889981293420 | K172517 | 000 |
| 10889981293413 | K172517 | 000 |
| 10889981306717 | K172517 | 000 |
| 10889981309541 | K172517 | 000 |
| 10889981148324 | K172517 | 000 |
| 10889981325183 | K172517 | 000 |
| 10889981303204 | K172517 | 000 |
| 10889981303198 | K172517 | 000 |
| 10889981260156 | K172517 | 000 |
| 10889981293444 | K172517 | 000 |
| 10889981293451 | K172517 | 000 |
| 10889981154691 | K172517 | 000 |
| 10889981257422 | K172517 | 000 |
| 10889981257415 | K172517 | 000 |
| 10889981284787 | K172517 | 000 |
| 10889981284770 | K172517 | 000 |
| 10889981284763 | K172517 | 000 |
| 10889981284756 | K172517 | 000 |
| 10889981284749 | K172517 | 000 |
| 10889981154721 | K172517 | 000 |
| 10889981154714 | K172517 | 000 |
| 10889981154707 | K172517 | 000 |
| 10889981260149 | K172517 | 000 |