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510(k) K112481

FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT by Ascension Orthopedic — Product Code KXE

K112481 is an FDA 510(k) premarket notification submitted by Ascension Orthopedic for the device "FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT". The FDA issued a decision of Substantially Equivalent on April 9, 2012. The device falls under product code KXE (Prosthesis, Wrist, Hemi-, Ulnar), a Class II device regulated under 21 CFR 888.3810. Ascension Orthopedic has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2012
Date Received
August 29, 2011
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 by Ascension Orthopedic

  • K140463 — INTEGRA EXTERNAL FIXATION SYSTEM (October 10, 2014)
  • K131360 — INTEGRA TITANIUM BONE WEDGE (August 7, 2013)
  • K130050 — TITAN REVERSE SHOULDER SYSTEM (June 18, 2013)
  • K112438 — TITAN MODULAR TOTAL SHOULDER SYSTEM (April 11, 2012)
  • K112278 — ASCENSION NUGRIP CMC IMPLANT (November 4, 2011)
  • K111799 — NUGAIT(TM) SUBTALAR IMPLANT SYSTEM (August 19, 2011)

Other clearances for product code KXE

  • K190599 — Aptis Medical Distal Radio Ulnar Joint Implant (May 3, 2019)
  • K142569 — Aptis Medical Distal Radio Ulnar Joint Implant (April 3, 2015)
  • K081025 — ISOELASTICU (November 21, 2008)
  • 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