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510(k) K193052

HBP6 Settable, Resorbable Hemostatic Bone Paste by Orthocon, Inc. — Product Code MTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2020
Date Received
November 1, 2019
Clearance Type
Traditional
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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  • K232771 — Montage Flowable Settable, Resorbable Bone Paste (February 16, 2024)
  • 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)
  • K213418 — MONTAGE Settable, Resorbable Hemostatic Bone Putty (August 30, 2023)
  • 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)
  • 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)
  • K152005 — MONTAGE Settable, Resorbable Hemostatic Bone Putty (October 15, 2015)