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510(k) K926047

ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW by Ace Orthopedic Manufacturing Co. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1993
Date Received
December 1, 1992
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 Ace Orthopedic Manufacturing Co.

  • K934962 — AIM SUPRACONDYLAR NAIL (March 22, 1994)
  • K934643 — ACE HUMERAL NAIL (March 22, 1994)
  • K936045 — ACE UNILATERAL FIXATOR II (February 22, 1994)
  • K920738 — ACE 100 DEGREES TUBULAR PLATE (July 27, 1992)
  • K813554 — ACE/KYLE CAPTURED HIP SCREW (January 12, 1982)
  • K810193 — TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG (March 20, 1981)
  • K801594 — ACE FISCHER EXTERNAL FIXATION DEVICE (September 9, 1980)
  • K791466 — ACE EXTERNAL BONE CLAMP PART #S11 (August 16, 1979)
  • K781839 — BONE CLAMP, ACE EXTERNAL (November 8, 1978)
  • K781841 — BAR, DISTRACTION (November 8, 1978)

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