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510(k) K954069

ACE CERVICAL TRACTION HALOZS, TONGS & PINS by Ace Medical Co. — Product Code HAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1995
Date Received
August 30, 1995
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 Medical Co.

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  • K955472 — ACE HUMERUS & RADIUS PLATES (April 1, 1996)
  • K955388 — ACE-DUPONT COMPOSITE RINGS (January 31, 1996)
  • K954485 — 6.5MM SOLID CANCELLOUS BONE SCREW (October 31, 1995)
  • K950618 — ACE SUPRACONDYLAR PLATE (May 10, 1995)
  • K933968 — ACE PELVIC STABILIZER (June 16, 1994)
  • K931652 — ACE 6.5 MM BONE SCREW (April 28, 1994)
  • K930592 — ACE UNIVERSAL RECONSTRUCTION PLATE (July 26, 1993)
  • K912598 — ACE CORTICAL BONE SCREW (November 27, 1991)

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)
  • K924606 — BREMER IMAGING TONGS-MRI MODEL (September 9, 1993)
  • K915530 — NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE (August 17, 1992)
  • K873693 — LEVTECH COMPOSITE TRACTION TONGS (February 5, 1988)