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510(k) K190599

Aptis Medical Distal Radio Ulnar Joint Implant by Aptis Medical, LLC — Product Code KXE

K190599 is an FDA 510(k) premarket notification submitted by Aptis Medical, LLC for the device "Aptis Medical Distal Radio Ulnar Joint Implant". The FDA issued a decision of Substantially Equivalent on May 3, 2019. The device falls under product code KXE (Prosthesis, Wrist, Hemi-, Ulnar), a Class II device regulated under 21 CFR 888.3810. Aptis Medical, LLC has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2019
Date Received
March 8, 2019
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 Aptis Medical, LLC

  • K142569 — Aptis Medical Distal Radio Ulnar Joint Implant (April 3, 2015)
  • K082839 — DISTAL RADIO-ULNAR JOINT IMPLANT (October 24, 2008)
  • K053119 — DISTAL RADIO-ULNAR JOINT IMPLANT (December 7, 2005)
  • K040497 — DISTAL RADIO-ULNAR JOINT IMPLANT (January 26, 2005)

Other clearances for product code KXE

  • K142569 — Aptis Medical Distal Radio Ulnar Joint Implant (April 3, 2015)
  • K112481 — FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT (April 9, 2012)
  • 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