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510(k) K981715

DISTAL RADIUS FRACTURE FIXATION PLATE by Avanta Orthopaedics, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1998
Date Received
May 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
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)

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