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510(k) DEN210044

CERAMENT G by Bonesupport AB — Product Code QRR

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
May 17, 2022
Date Received
September 28, 2021
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
Device Class
Class II
Regulation Number
888.3046
Review Panel
OR
Submission Type

A resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial is a resorbable implant intended to fill bony defects of the extremities where there is an increased risk of infection. It is intended to resorb over time and be replaced by new bone. The product is intended for reduction of recurrence of chronic osteomyelitis of long bones. It is not intended to treat infection.

Other clearances by Bonesupport AB

  • K234008 — CERAMENT G (March 13, 2024)
  • K240459 — Cerament Bone Void Filler (March 5, 2024)
  • K201535 — Cerament Bone Void Filler (October 16, 2020)
  • K090871 — CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 (September 4, 2009)
  • K073316 — CERAMENT BONE VOID FILLER, MODEL A0210 (June 20, 2008)
  • K051951 — CERAMENT BONE VOID FILLER (September 28, 2005)

Other clearances for product code QRR

  • K234008 — CERAMENT G (March 13, 2024)