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510(k) K864746

BREMER HALO SYSTEM by Bremer Orthopedics — Product Code HAX

K864746 is an FDA 510(k) premarket notification submitted by Bremer Orthopedics for the device "BREMER HALO SYSTEM". The FDA issued a decision of Substantially Equivalent on December 22, 1986. 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
December 22, 1986
Date Received
December 5, 1986
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)
  • 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