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510(k) K060987

OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 by Cp Medical — Product Code MTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2006
Date Received
April 10, 2006
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

Other clearances by Cp Medical

  • K173922 — C-PTFETM Surgical Suture (March 26, 2018)
  • K094028 — CP-FIBER (ORTHOFIBER) (March 18, 2010)
  • K072229 — MONOSWIFT (October 5, 2007)
  • K071550 — PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS (July 18, 2007)
  • K041894 — ORTHOFIBER (September 17, 2004)
  • K034062 — CP SLEEVE AND RIVER SLEEVE (January 30, 2004)
  • K024372 — CP MEDICAL BONE WAX (June 19, 2003)
  • K030786 — MONO-SWIFT (May 6, 2003)
  • K030351 — STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE (March 28, 2003)
  • K023710 — VISORB SWIFT (January 17, 2003)

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  • 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)