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510(k) K152005

MONTAGE Settable, Resorbable Hemostatic Bone Putty by Orthocon, Inc. — Product Code MTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2015
Date Received
July 20, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wax, Bone
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

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  • K232998 — Montage- XT Settable, Resorbable Hemostatic Bone Putty (October 12, 2023)
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Other clearances for product code MTJ

  • K232998 — Montage- XT Settable, Resorbable Hemostatic Bone Putty (October 12, 2023)
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  • K231386 — Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste (July 11, 2023)
  • K200452 — Meril-Bonewax (March 27, 2023)
  • K220315 — MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty (March 11, 2022)
  • K202363 — HBP7 Settable Hemostatic Bone Putty (January 19, 2021)
  • K193052 — HBP6 Settable, Resorbable Hemostatic Bone Paste (March 27, 2020)
  • K191140 — MONTAGE-QS Settable, Resorbable Hemostatic Bone (July 18, 2019)
  • K153317 — HEMASORBPLUS Resorbable Hemostatic Bone Putty (November 30, 2016)
  • K153095 — ROP Resorbable Hemostasis Material (February 17, 2016)