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510(k) K081025

ISOELASTICU by Remi Sciences, Inc. — Product Code KXE

K081025 is an FDA 510(k) premarket notification submitted by Remi Sciences, Inc. for the device "ISOELASTICU". The FDA issued a decision of Substantially Equivalent on November 21, 2008. The device falls under product code KXE (Prosthesis, Wrist, Hemi-, Ulnar), a Class II device regulated under 21 CFR 888.3810.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2008
Date Received
April 10, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Hemi-, Ulnar
Device Class
Class II
Regulation Number
888.3810
Review Panel
OR
Submission Type

Other clearances for product code KXE

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  • K142569 — Aptis Medical Distal Radio Ulnar Joint Implant (April 3, 2015)
  • K112481 — FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT (April 9, 2012)
  • K082839 — DISTAL RADIO-ULNAR JOINT IMPLANT (October 24, 2008)
  • K061146 — SBI ULNAR HEAD IMPLANT (July 19, 2006)
  • K053119 — DISTAL RADIO-ULNAR JOINT IMPLANT (December 7, 2005)
  • K052137 — ASCENSION MUH (November 3, 2005)
  • K040497 — DISTAL RADIO-ULNAR JOINT IMPLANT (January 26, 2005)
  • K042902 — HERBERT ULNAR HEAD PROSTHESIS SYSTEM (December 27, 2004)
  • K033930 — KAPP CUSTOM ULNAR HEAD WRIST IMPLANT (July 28, 2004)

FDA data resources