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510(k) K243477

Universal Tendon Spacer by Askorn Medical — Product Code HXA

K243477 is an FDA 510(k) premarket notification submitted by Askorn Medical for the device "Universal Tendon Spacer". The FDA issued a decision of Substantially Equivalent on January 10, 2025. The device falls under product code HXA (Prosthesis, Tendon, Passive), a Class II device regulated under 21 CFR 888.3025.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2025
Date Received
November 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Tendon, Passive
Device Class
Class II
Regulation Number
888.3025
Review Panel
OR
Submission Type

Other clearances for product code HXA

  • K000019 — SINGLE SIZE TENDON SPACER (March 29, 2000)
  • K973385 — OVAL SHAPES (December 5, 1997)
  • K964359 — AVANTA ORTHOPAEDICS TENDON SPACER (March 25, 1997)
  • K930125 — PHOENIX BONE SCREWS PBS-TYPE SERIES (December 30, 1993)
  • K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC (September 28, 1987)
  • K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC (September 28, 1987)
  • K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC (September 28, 1987)
  • K853438 — H-H HUNTER ACTIVE TENDON IMPLANT (September 30, 1985)
  • K781943 — TENDON ROD MODEL OR41PO3-6 (December 4, 1978)
  • K780320 — PASSIVE TENDON IMPLANT (March 17, 1978)

FDA data resources