OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
FDA 510(k) clearance K081356 · decided 2008-07-09
Clearance details
- K-number
- K081356
- Device name
- OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
- Applicant
- Mylad Orthopedic Solutions, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-05-14
- Decision date
- 2008-07-09
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mclean, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.