Atlas FDA

Hexanium TLIF

FDA 510(k) clearance K210359 · decided 2021-03-10

Clearance details

K-number
K210359
Device name
Hexanium TLIF
Applicant
Spinevision, S.A.S.
Decision
Substantially Equivalent
Date received
2021-02-08
Decision date
2021-03-10
Days to decision
30 days
Clearance type
Special
Product code
MAX
Device class
2
Regulation number
888.3080
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Batiment E, FR
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.