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510(k) K934962

AIM SUPRACONDYLAR NAIL by Ace Orthopedic Manufacturing Co. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1994
Date Received
October 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Ace Orthopedic Manufacturing Co.

  • K934643 — ACE HUMERAL NAIL (March 22, 1994)
  • K936045 — ACE UNILATERAL FIXATOR II (February 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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