LEFORTE SYSTEM BONE PLATE & SCREW
FDA 510(k) clearance K112457 · decided 2012-05-18
Clearance details
- K-number
- K112457
- Device name
- LEFORTE SYSTEM BONE PLATE & SCREW
- Applicant
- Arkin Consulting Group
- Decision
- Substantially Equivalent
- Date received
- 2011-08-26
- Decision date
- 2012-05-18
- Days to decision
- 266 days
- Clearance type
- Special
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.