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510(k) K061206

ACUTE BONE SCREW by Acute Innovations, LLC — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2006
Date Received
May 1, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Acute Innovations, LLC

  • K120163 — ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM (February 17, 2012)
  • K113318 — ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM (January 12, 2012)
  • K101170 — ACUTE INNOVATIONS STERNAL FIXATION SYSTEM (September 17, 2010)
  • K081588 — RE-ZORB PLATING SYSTEM (September 3, 2008)

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