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510(k) K241555

Moldable Bone Void Filler and Moldable Bone Void Filler + CCC by Rti Surgical, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2025
Date Received
May 31, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

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  • K172343 — Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology (October 23, 2017)
  • K163673 — Fortilink™-C with TETRAfuse™ 3D Technology (May 23, 2017)
  • K142070 — FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS (October 27, 2014)
  • K132850 — BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE P (March 31, 2014)

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  • K243949 — OsteoFlo HydroFiber (May 28, 2025)
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