Manufacturer
Genesys SpineGenesys Spine Sacroiliac Joint Fusion System with Navigation
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K233595
- Device name
- Genesys Spine Sacroiliac Joint Fusion System with Navigation
- Company
- Genesys Spine
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2023-11-08
- Decision date
- 2024-03-29
- Submission type
- Traditional
- Technology type
- Software Navigation(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Spine Surgery
- Classification source
- AI classified
Intended Use
) to legally marketed
Summary parsed at:2026-06-19 05:29:33 UTC
Predicate devices
0No predicate K numbers were extracted
The Summary PDF may not be parsed yet, or this submission may not cite predicate devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K233595 as a predicate