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510(k) K010847

K'FIX by Avanta Orthopaedics, Inc. — Product Code NDL

K010847 is an FDA 510(k) premarket notification submitted by Avanta Orthopaedics, Inc. for the device "K'FIX". The FDA issued a decision of Substantially Equivalent on June 19, 2001. The device falls under product code NDL (Pin, Fixation, Smooth, Metallic), a Class II device regulated under 21 CFR 888.3040. Avanta Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2001
Date Received
March 21, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth, Metallic
Device Class
Class II
Regulation Number
888.3040
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)
  • 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 NDL

FDA data resources