DYNA LOCKING IM NAIL
FDA 510(k) clearance K092771 · decided 2009-12-02
Clearance details
- K-number
- K092771
- Device name
- DYNA LOCKING IM NAIL
- Applicant
- U&I Corp.
- Decision
- Substantially Equivalent
- Date received
- 2009-09-09
- Decision date
- 2009-12-02
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Uijungbu, Gyeonggi-Do, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.