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510(k) K231270

Montage Flowable Settable, Resorbable Bone Paste by Orthocon, Inc. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2023
Date Received
May 2, 2023
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

Other clearances by Orthocon, Inc.

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  • K243506 — Montage-XT Settable Bone Putty (November 18, 2024)
  • K241027 — Permatage Settable Bone Putty (September 26, 2024)
  • K233566 — Montage-XT Settable, Resorbable Bone Putty (August 21, 2024)
  • K242050 — Montage Settable Bone Putty (July 29, 2024)
  • K232771 — Montage Flowable Settable, Resorbable Bone Paste (February 16, 2024)
  • K231475 — MONTAGE-QS Settable, Resorbable Bone Putty (October 12, 2023)
  • K232998 — Montage- XT Settable, Resorbable Hemostatic Bone Putty (October 12, 2023)

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  • K251193 — Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (June 12, 2025)
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  • K250141 — Synthecure Synthetic Calcium Sulfate (May 16, 2025)