Product code KXE— Orthopedic
DISTAL RADIO-ULNAR JOINT IMPLANT
- Classification name
- Prosthesis, Wrist, Hemi-, Ulnar
- Device class
- Class 2
- Regulation
- 21 CFR 888.3810
- Advisory panel
- Orthopedic
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code KXE
FDA has cleared devices under product code KXE between 1979 and 2019, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2019
- 2015
- 2012
- 2008
- 2006
- 2005
- 2004
- 2002
- 2001
- 1998
- 1981
- 1979
Top applicants under product code KXE
Recent clearances under product code KXE
- K190599 — Aptis Medical Distal Radio Ulnar Joint Implant
- K142569 — Aptis Medical Distal Radio Ulnar Joint Implant
- K112481 — FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
- K081025 — ISOELASTICU
- K082839 — DISTAL RADIO-ULNAR JOINT IMPLANT
- K061146 — SBI ULNAR HEAD IMPLANT
- K053119 — DISTAL RADIO-ULNAR JOINT IMPLANT
- K052137 — ASCENSION MUH
- K040497 — DISTAL RADIO-ULNAR JOINT IMPLANT
- K042902 — HERBERT ULNAR HEAD PROSTHESIS SYSTEM
- K033930 — KAPP CUSTOM ULNAR HEAD WRIST IMPLANT
- K020274 — WMT MODULAR ULNAR HEAD IMPLANT
- K010786 — ULNAR HEAD IMPLANT
- K982268 — ULNAR HEAD IMPLANT
- K812053 — SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
- K790125 — ULNAR HEAD PROTHESIS
Data sourced from openFDA. This site is unofficial and independent of the FDA.