IB3D PL Spinal System— 510(k) K241164
Substantially EquivalentMedicrea International S.A.S. (Medtronic)
FDA 510(k) clearance K241164 for IB3D PL Spinal System, Substantially Equivalent on 2024-09-06. Applicant: Medicrea International S.A.S. (Medtronic). Device class: 2.
Clearance details
- Applicant
- Medicrea International S.A.S. (Medtronic)
- Product code
- Code MAX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rillieux-La-Pape, FR
Recent devices under product code MAX
view allMore clearances from Medicrea International S.A.S. (Medtronic)
view allAdverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K241164
K-number listed on FDA's recall record- Z-1038-2026 — Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
- Z-1039-2026 — Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K241164.
Data sourced from openFDA. This site is unofficial and independent of the FDA.