510(k) clearances

SC Medica FFX

Sc Medica · Unknown

K232468Substantially EquivalentTraditionalMRW
Open FDA's page for this record
Third party flag
N
City
Strasbourg
Advisory committee description
Unknown
Address 1
3 Quai Kleber - Tour Sebastopol
Statement or summary
Summary
Product code
MRW
Zip code
67000
Applicant
Sc Medica
Decision date
2024-05-09
Decision code
SESE
Country code
FR
Device name
SC Medica FFX
Contact
Camille Srour
K number
K232468
Date received
2023-08-15
Review advisory committee
OR
Postal code
67000
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
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.