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510(k) K964359

AVANTA ORTHOPAEDICS TENDON SPACER by Avanta Orthopaedics, Inc. — Product Code HXA

K964359 is an FDA 510(k) premarket notification submitted by Avanta Orthopaedics, Inc. for the device "AVANTA ORTHOPAEDICS TENDON SPACER". The FDA issued a decision of Substantially Equivalent on March 25, 1997. The device falls under product code HXA (Prosthesis, Tendon, Passive), a Class II device regulated under 21 CFR 888.3025. Avanta Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1997
Date Received
November 1, 1996
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 by Avanta Orthopaedics, Inc.

  • K030881 — AVANTA CARPAL FUSION PLATING SYSTEM (April 10, 2003)
  • K021859 — WRIST IMPLANT (December 2, 2002)
  • K023604 — MODIFICATION TO RADIAL HEAD IMPLANT (November 27, 2002)
  • K013629 — FINGER JOINT PROSTHESIS (January 25, 2002)
  • K011819 — RADIAL HEAD IMPLANT (June 19, 2001)
  • K010847 — K'FIX (June 19, 2001)
  • K003033 — SCAPHIX, STAPLE, FIXATION, BONE (May 30, 2001)
  • K010786 — ULNAR HEAD IMPLANT (April 11, 2001)
  • K002644 — RADIAL HEAD IMPLANT (November 20, 2000)
  • K990596 — DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM (April 29, 1999)

Other clearances for product code HXA

  • K243477 — Universal Tendon Spacer (January 10, 2025)
  • K000019 — SINGLE SIZE TENDON SPACER (March 29, 2000)
  • K973385 — OVAL SHAPES (December 5, 1997)
  • K930125 — PHOENIX BONE SCREWS PBS-TYPE SERIES (December 30, 1993)
  • K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC (September 28, 1987)
  • K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC (September 28, 1987)
  • K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC (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