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510(k) K801594

ACE FISCHER EXTERNAL FIXATION DEVICE by Ace Orthopedic Manufacturing Co. — Product Code HXK

K801594 is an FDA 510(k) premarket notification submitted by Ace Orthopedic Manufacturing Co. for the device "ACE FISCHER EXTERNAL FIXATION DEVICE". The FDA issued a decision of Substantially Equivalent on September 9, 1980. The device falls under product code HXK (Holder, Needle; Orthopedic), a Class I device regulated under 21 CFR 888.4540. Ace Orthopedic Manufacturing Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1980
Date Received
July 14, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Needle; Orthopedic
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Ace Orthopedic Manufacturing Co.

  • K934643 — ACE HUMERAL NAIL (March 22, 1994)
  • K934962 — AIM SUPRACONDYLAR 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)
  • K791466 — ACE EXTERNAL BONE CLAMP PART #S11 (August 16, 1979)
  • K781841 — BAR, DISTRACTION (November 8, 1978)
  • K781840 — EXTERNAL ARTICULATION (November 8, 1978)

Other clearances for product code HXK

  • K890167 — HOLDER, NEEDLE (February 3, 1989)
  • K872989 — MICRINS NEEDLE HOLDER (August 21, 1987)
  • K860018 — FISCHER WIRE/PIN CLAMP (February 7, 1986)
  • K772388 — CONVERSE-GILLIES NEEDLE HOLDER (January 20, 1978)

FDA data resources