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510(k) K834047

PMT-HALO/ORTHOPEDIC JACKET SYSTEM by Progress Mankind Technology — Product Code HAX

K834047 is an FDA 510(k) premarket notification submitted by Progress Mankind Technology for the device "PMT-HALO/ORTHOPEDIC JACKET SYSTEM". The FDA issued a decision of Substantially Equivalent on February 17, 1984. The device falls under product code HAX (Tong, Skull For Traction), a Class II device regulated under 21 CFR 882.5960. Progress Mankind Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1984
Date Received
November 23, 1983
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 Progress Mankind Technology

  • K883314 — PMT 3721-1 EPIDURAL KIT (October 28, 1988)
  • K881616 — PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1 (September 9, 1988)
  • K871663 — PMT TRACTION TONGS (June 19, 1987)
  • K854157 — PMT ACCUPRESSURE INFUSION SYSTEM 3601 (February 13, 1986)
  • K845035 — ELECTRODE FOR NEUROLOGICAL SURGERY 2111 (July 30, 1985)
  • K845036 — TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600 (June 26, 1985)
  • K831329 — PMT VAXIOM STEREOTACTIC SYS #FX001 (June 15, 1983)
  • K830530 — TEMP TRACE (April 6, 1983)
  • K812744 — LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER (December 3, 1981)
  • K810627 — MODEL 1301 BIOTAC (TM) (April 2, 1981)

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