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510(k) K052248

DORSAL NAIL PLATE, ANATOMICAL by Hand Innovations, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2005
Date Received
August 18, 2005
Clearance Type
Special
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 Hand Innovations, LLC

  • K061748 — FRAGMENT PLATE SYSTEM (July 17, 2006)
  • K060864 — MULTIDIRECTIONAL THREADED PEG (April 28, 2006)
  • K060294 — DIAPHYSEAL PLATE (March 22, 2006)
  • K060290 — SHOULDER FIXATION SYSTEM (February 27, 2006)
  • K052294 — SHOULDER NAIL PLATE (October 21, 2005)
  • K051728 — MODIFICATION TO SHOULDER FIXATION SYSTEM (July 20, 2005)
  • K050932 — DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM (April 26, 2005)
  • K042059 — SHOULDER FIXATION SYSTEM (September 30, 2004)
  • K041157 — MODIFICATION TO SMALL BONE FIXATION SYSTEM (July 30, 2004)
  • K041081 — FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES (July 1, 2004)

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