IMPIX 3D Print Cages
FDA 510(k) clearance K163595 · decided 2017-11-13
Clearance details
- K-number
- K163595
- Device name
- IMPIX 3D Print Cages
- Applicant
- Medicrea International SA
- Decision
- Substantially Equivalent
- Date received
- 2016-12-21
- Decision date
- 2017-11-13
- Days to decision
- 327 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 |
|---|---|---|
| IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062 recall (Z-2452-2023) | Medicrea International | 2023-08-24 |