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510(k) K070012

POLYBONE by Kyung Won Medical Co., Ltd. — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2007
Date Received
January 3, 2007
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 Kyung Won Medical Co., Ltd.

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  • K092194 — POLYBONE DENTAL (June 16, 2010)
  • K082338 — POLYBONE GRANULE & BLOCK (October 16, 2008)

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  • 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)
  • K162864 — OsteoVation Impact (January 13, 2017)
  • K143661 — DirectInject (September 2, 2015)
  • K102018 — NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY (September 23, 2010)