Atlas FDA

IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)

FDA 510(k) clearance K253577 · decided 2025-12-19

Clearance details

K-number
K253577
Device name
IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
Applicant
Medicrea International S.A.S. (Medtronic)
Decision
Substantially Equivalent
Date received
2025-11-17
Decision date
2025-12-19
Days to decision
32 days
Clearance type
Special
Product code
MAX
Device class
2
Regulation number
888.3080
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Rillieux-La-Pape, FR
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.