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510(k) K980689

FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM by Friddle'S Orthopedic Appliances, Inc. — Product Code HAX

K980689 is an FDA 510(k) premarket notification submitted by Friddle'S Orthopedic Appliances, Inc. for the device "FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM". The FDA issued a decision of Substantially Equivalent on February 18, 1999. The device falls under product code HAX (Tong, Skull For Traction), a Class II device regulated under 21 CFR 882.5960.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1999
Date Received
February 23, 1998
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 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)
  • 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)
  • K873693 — LEVTECH COMPOSITE TRACTION TONGS (February 5, 1988)

FDA data resources