Manufacturer
SeaSpine Orthopedics CorporationFLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
SeaSpine Orthopedics Corporation
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
- K243659
- Device name
- FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2024-11-27
- Decision date
- 2025-04-02
- Submission type
- Traditional
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 K243659 as a predicate