Manufacturer
Life Spine, Inc.Product reference
Illustration for identification — verify against the FDA-cleared configuration.
Source: Web
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
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
- K260571
- Device name
- SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
- Company
- Life Spine, Inc.
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2026-02-19
- Decision date
- 2026-06-02
- Submission type
- Traditional
- Technology type
- Robotic Navigation(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Spine Surgery
- Classification source
- AI classified
Predicate devices
0No predicate K numbers were extracted
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Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K260571 as a predicate