AERO MIS Facet Fusion System
Aurora Spine · Unknown
Open FDA's page for this record- Third party flag
- N
- City
- Carlsbad
- Advisory committee description
- Unknown
- Address 1
- 1930 Palomar Pt. Way Suite 103
- Statement or summary
- Summary
- Product code
- MRW
- Zip code
- 92009
- Applicant
- Aurora Spine
- Decision date
- 2025-03-24
- Decision code
- SESE
- Country code
- US
- Device name
- AERO MIS Facet Fusion System
- Contact
- Laszlo Garamszegi
- K number
- K243865
- State
- CA
- Date received
- 2024-12-17
- Review advisory committee
- OR
- Postal code
- 92009
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- System, Facet Screw Spinal Device
- Medical specialty description
- Unknown
- Device class
- U
- Registration number
- 9617297, 3018094310, 3005739886, 3008868758, 1057425, 8043792, 1835572, 3005706667, 2134285, 3005977257, 3019837678, 3006846753, 3030412764, 3008114965, 3003477135, 2953359, 3009554293, 2134470, 3006404071, 3017528621, 3005819474, 3003761012, 3039103971, 3000203391, 3010462278, 3009732568, 3016050940, 2135156, 3004188066, 3007922509, 3011302058, 3006172536, 3006791286, 3010162973, 2031966, 3009888740, 3031232974, 3024999441, 2954750, 1824199 +64 more
- FEI number
- 1000477302, 3018094310, 3005739886, 3008868758, 3005706667, 3002808269, 1000306303, 3005977257, 3019837678, 3006846753, 3003015552, 3030412764, 3008114965, 3003477135, 3009554293, 3006404071, 3017528621, 1000136451, 3005819474, 3003761012, 3039103971, 3003112432, 3000203391, 3010462278, 3009732568, 3002287318, 3016050940, 3004188066, 3007922509, 3009256700, 3011302058, 3006172536, 3006791286, 3009888740, 3000205591, 3003200961, 3031232974, 3024999441, 3000215273, 1824199 +64 more