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510(k) K936045

ACE UNILATERAL FIXATOR II by Ace Orthopedic Manufacturing Co. — Product Code JEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1994
Date Received
December 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Invasive
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)
  • K926047 — ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW (March 31, 1993)
  • 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)
  • K781840 — EXTERNAL ARTICULATION (November 8, 1978)
  • K781839 — BONE CLAMP, ACE EXTERNAL (November 8, 1978)

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  • K171863 — Anjon Bremer Halo System (March 19, 2018)
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  • K132731 — DIGIFIX EXTERNAL FIXATION SYSTEM (January 10, 2014)
  • K102885 — HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020 (January 14, 2011)
  • K082679 — LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X (April 7, 2009)
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