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510(k) K013629

FINGER JOINT PROSTHESIS by Avanta Orthopaedics, Inc. — Product Code KYJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2002
Date Received
November 5, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Finger, Constrained, Polymer
Device Class
Class II
Regulation Number
888.3230
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)
  • K010847 — K'FIX (June 19, 2001)
  • K011819 — RADIAL HEAD IMPLANT (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)
  • K982268 — ULNAR HEAD IMPLANT (December 4, 1998)

Other clearances for product code KYJ

  • K233670 — Ascension Silicone MCP; Ascension Silicone PIP (December 14, 2023)
  • K220142 — BRM Digitalis Spacer (April 4, 2023)
  • K211385 — KeriFlex® MCP and PIP Finger Joint Prostheses (July 27, 2022)
  • K140453 — OSTEOTEC SILICONE FINGER IMPLANT (April 17, 2015)
  • K083107 — MODIFICATION TO DEPUY NEUFLEX PIP FINGER (February 9, 2009)
  • K082231 — ASCENSION SILICONE PIP (January 12, 2009)
  • K022892 — ASCENSION SILLICONE MCP (November 25, 2002)
  • K001922 — DEPUY NEUFLEX PIP FINGER (August 29, 2000)
  • K970544 — DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS (September 12, 1997)
  • K931588 — SUTTER PROXIMAL INTERPHALANGEAL JOINT (March 10, 1994)