Para-Fix External Fixation System
FDA 510(k) clearance K230067 · decided 2023-09-22
Clearance details
- K-number
- K230067
- Device name
- Para-Fix External Fixation System
- Applicant
- New Paradigm Biomedical
- Decision
- Substantially Equivalent
- Date received
- 2023-01-09
- Decision date
- 2023-09-22
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- LXT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Needham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.