ENSPLINTRX BONE FIXATION SYSTEM
FDA 510(k) clearance K071809 · decided 2008-02-21
Clearance details
- K-number
- K071809
- Device name
- ENSPLINTRX BONE FIXATION SYSTEM
- Applicant
- Sonoma Orthopedic Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-07-02
- Decision date
- 2008-02-21
- Days to decision
- 234 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Santa Rosa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.