Home / 510(k) Clearances / K162864

510(k) K162864

OsteoVation Impact by Skeletal Kinetics, LLC — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2017
Date Received
October 13, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methyl Methacrylate For Cranioplasty
Device Class
Class II
Regulation Number
882.5300
Review Panel
NE
Submission Type

Other clearances by Skeletal Kinetics, LLC

  • K132211 — SKAFFOLD NMX BONE VOID FILLER (August 4, 2014)
  • K120354 — BETA-TCP GRANULES (March 21, 2013)
  • K112383 — CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER (February 7, 2012)
  • K111538 — SKAFFOLD CIS (October 25, 2011)
  • K100986 — CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION (July 20, 2010)
  • K051784 — OSTEOVATION CMF BONE VOID FILLER (July 20, 2005)
  • K051123 — CALLOS IMPACT AND INJECT BONE VOID FILLER (June 3, 2005)
  • K042072 — CALLOS CMF BONE VOID FILLER (September 16, 2004)
  • K030554 — CALLOS (May 20, 2003)

Other clearances for product code GXP

  • K253732 — Permatage Flowable, Settable Bone Paste (March 13, 2026)
  • K253854 — MONTAGE XT Cranial Cement (January 2, 2026)
  • K241027 — Permatage Settable Bone Putty (September 26, 2024)
  • K232771 — Montage Flowable Settable, Resorbable Bone Paste (February 16, 2024)
  • K231475 — MONTAGE-QS Settable, Resorbable Bone Putty (October 12, 2023)
  • K221933 — MONTAGE Settable, Resorbable Bone Putty (January 13, 2023)
  • K182742 — DB-CMF (June 20, 2019)
  • K143661 — DirectInject (September 2, 2015)
  • K102018 — NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY (September 23, 2010)
  • K091382 — KRYPTONITE BONE CEMENT (November 16, 2009)