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510(k) K190652

OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant by OSSIO , Ltd. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2020
Date Received
March 13, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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Other clearances for product code HTY

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  • K231272 — OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimm (December 1, 2023)
  • K231147 — Hammerdesis™ Interphalangeal Fusion System (September 14, 2023)
  • K230750 — OSSIOfiber® Cannulated Trimmable Fixation Nail (September 13, 2023)
  • K231905 — Electro-Spec Steri-Caps (August 14, 2023)