510(k) K172517 ยท OLO Orthopedic Stereotaxic Instrument
SeaSpine Navigation System
| Applicant | SeaSpine Orthopedics Corporation, Carlsbad CA, US |
| Decision | Substantially Equivalent, May 11, 2018 |
| Received | Aug 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172517
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2025 | SEASPINE ORTHOPEDICS CORPORATION Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments:
Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-4001 Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.