IB3D™ PL Spinal System
FDA 510(k) clearance K241164 · decided 2024-09-06
Clearance details
- K-number
- K241164
- Device name
- IB3D™ PL Spinal System
- Applicant
- Medicrea International S.A.S. (Medtronic)
- Decision
- Substantially Equivalent
- Date received
- 2024-04-26
- Decision date
- 2024-09-06
- Days to decision
- 133 days
- Clearance type
- Traditional
- 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
| Record | Firm | Date |
|---|---|---|
| Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 recall (Z-1038-2026) | Medicrea International | 2026-01-09 |
| Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174 recall (Z-1039-2026) | Medicrea International | 2026-01-09 |