SIros-X System— 510(k) K252322
Substantially EquivalentGenesys Spine
FDA 510(k) clearance K252322 for SIros-X System, Substantially Equivalent on 2025-10-22. Applicant: Genesys Spine. Device class: 2.
Clearance details
- Applicant
- Genesys Spine
- Product code
- Code OUR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code OUR
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view all- K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System
- K233595 — Genesys Spine Sacroiliac Joint Fusion System with Navigation
- K233594 — Genesys Spine 3DP AIS-C II Cervical Interbody System
- K220096 — Genesys Spine 3DP Lumbar Interbody System
- K191489 — Genesys Spine 3DP Cervical Interbody System
Adverse events under product code OUR
product code OUR- Death
- 3
- Injury
- 347
- Total
- 350
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.