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FDA 510(k), K123672, INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
FDA 510(k), K123672, INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
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510(K) Number: K123672
Device Name: INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
Manufacturer: INION OY
Device Classification Name: screw, fixation, bone
Regulation Number: 888.3040
Classification Product Code: HWC
Date Received: 11/29/2012
Decision Date: 02/27/2013
Regulation Medical Specialty: Orthopedic
Device Name: INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
Manufacturer: INION OY
Device Classification Name: screw, fixation, bone
Regulation Number: 888.3040
Classification Product Code: HWC
Date Received: 11/29/2012
Decision Date: 02/27/2013
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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