LEFORTE SYSTEM BONE PLATE
FDA 510(k) clearance K023360 · decided 2002-10-25
Clearance details
- K-number
- K023360
- Device name
- LEFORTE SYSTEM BONE PLATE
- Applicant
- Jeil Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2002-10-07
- Decision date
- 2002-10-25
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- KTW
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Deer Field, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.