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FDA 510(k), K170249, GRAVITY™ Syndesmosis LP
FDA 510(k), K170249, GRAVITY™ Syndesmosis LP
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510(K) Number: K170249
Device Name: GRAVITY™ Syndesmosis LP
Manufacturer: MICHAEL MULLINS
Device Classification Name: Washer, Bolt Nut
Regulation Number: HTN
Classification Product Code: 01/27/2017
Date Received: 06/30/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: GRAVITY™ Syndesmosis LP
Manufacturer: MICHAEL MULLINS
Device Classification Name: Washer, Bolt Nut
Regulation Number: HTN
Classification Product Code: 01/27/2017
Date Received: 06/30/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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