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510(k) K810193

TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG by Ace Orthopedic Manufacturing Co. — Product Code HAX

K810193 is an FDA 510(k) premarket notification submitted by Ace Orthopedic Manufacturing Co. for the device "TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG". The FDA issued a decision of Substantially Equivalent on March 20, 1981. The device falls under product code HAX (Tong, Skull For Traction), a Class II device regulated under 21 CFR 882.5960. Ace Orthopedic Manufacturing Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1981
Date Received
January 23, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tong, Skull For Traction
Device Class
Class II
Regulation Number
882.5960
Review Panel
NE
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)
  • K801594 — ACE FISCHER EXTERNAL FIXATION DEVICE (September 9, 1980)
  • 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 HAX

  • K090733 — PMT HALO SYSTEM (July 28, 2009)
  • K071173 — RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D (May 25, 2007)
  • K051918 — RESOLVE OPEN BACK HALO RINGS (August 17, 2005)
  • K023959 — JEROME GLASS RING (February 21, 2003)
  • K003662 — SPINE WORKS COLLAR (July 9, 2001)
  • K980689 — FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM (February 18, 1999)
  • K930021 — J TONGS (December 6, 1995)
  • K954069 — ACE CERVICAL TRACTION HALOZS, TONGS & PINS (October 12, 1995)
  • K924606 — BREMER IMAGING TONGS-MRI MODEL (September 9, 1993)
  • K915530 — NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE (August 17, 1992)

FDA data resources