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510(k) K091382

KRYPTONITE BONE CEMENT by Doctors Research Group, Inc. — Product Code GXP

K091382 is an FDA 510(k) premarket notification submitted by Doctors Research Group, Inc. for the device "KRYPTONITE BONE CEMENT". The FDA issued a decision of SESU on November 16, 2009. The device falls under product code GXP (Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300.

Clearance Details

Decision
SESU ()
Decision Date
November 16, 2009
Date Received
May 11, 2009
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

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  • 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)
  • K162864 — OsteoVation Impact (January 13, 2017)
  • K143661 — DirectInject (September 2, 2015)

FDA data resources