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510(k) K132735

AXIA RADIAL HEAD SYSTEM by Imds (Innovative MEdical Device Systems) - Leis ME — Product Code KWI

K132735 is an FDA 510(k) premarket notification submitted by Imds (Innovative MEdical Device Systems) - Leis ME for the device "AXIA RADIAL HEAD SYSTEM". The FDA issued a decision of Substantially Equivalent on January 7, 2014. The device falls under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), a Class II device regulated under 21 CFR 888.3170.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2014
Date Received
September 3, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class
Class II
Regulation Number
888.3170
Review Panel
OR
Submission Type

Other clearances for product code KWI

  • K233592 — BioPoly Radial Head Implant (March 13, 2024)
  • K231188 — ALIGN Radial Head System (September 28, 2023)
  • K213563 — DePuy Synthes Radial Head Replacement System (March 18, 2022)
  • K212872 — Avenger Radial Head System (December 17, 2021)
  • K192754 — Avenger Radial Head System (January 7, 2020)
  • K183618 — Revolution Radial Head (May 17, 2019)
  • K172688 — Align Radial Head System (December 22, 2017)
  • K131845 — ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUM (September 30, 2013)
  • K112030 — SYNTHES RADIAL HEAD PROSTHESIS SYSTEM (June 19, 2012)
  • K092721 — ALIGN RADIAL HEAD SYSTEM (August 3, 2010)

FDA data resources