DYNA-EXTOR II
FDA 510(k) clearance K110426 · decided 2011-11-02
Clearance details
- K-number
- K110426
- Device name
- DYNA-EXTOR II
- Applicant
- Bk Meditech, Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-02-14
- Decision date
- 2011-11-02
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- KTT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.