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510(k) K884340

AMX-110, AMX-II AND AMX-III by Dyna-Med — Product Code ILZ

K884340 is an FDA 510(k) premarket notification submitted by Dyna-Med for the device "AMX-110, AMX-II AND AMX-III". The FDA issued a decision of Substantially Equivalent on January 24, 1989. The device falls under product code ILZ (Accessories, Traction), a Class I device regulated under 21 CFR 890.5925. Dyna-Med has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1989
Date Received
October 14, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Traction
Device Class
Class I
Regulation Number
890.5925
Review Panel
PM
Submission Type

Other clearances by Dyna-Med

  • K884578 — POLARIX 2 AND POLARIX 2E (February 9, 1989)
  • K863504 — OBSTETRICAL KIT (October 22, 1986)
  • K760258 — BITE STICK, DYNA (July 26, 1976)

Other clearances for product code ILZ

  • K921711 — FLEXION DISTRATION SUPPORT (July 13, 1992)
  • K895382 — VIBRA-TRAC TRACTION TABLE (October 16, 1989)
  • K852398 — VECTOR BAR SUSPENSION/TRACTION UNIT (August 12, 1985)
  • K844490 — TRACTION ACCESSORIES (February 21, 1985)
  • K831135 — SAUNDERS #7080 CERVICAL TRACTION SYS (June 24, 1983)
  • K830245 — HEAD HALTER (March 9, 1983)
  • K823659 — PELVIC TRACTION BELT (December 30, 1982)
  • K823166 — PELVIC TRACTION BELT (November 10, 1982)
  • K820663 — BOGER AUTO-TRACTION DEVICE (May 3, 1982)
  • K791808 — CERVI-TRAC (October 1, 1979)

FDA data resources