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510(k) K811298

EXECUTIVE COLLAR by Orthomedics — Product Code IQK

K811298 is an FDA 510(k) premarket notification submitted by Orthomedics for the device "EXECUTIVE COLLAR". The FDA issued a decision of Substantially Equivalent on May 27, 1981. The device falls under product code IQK (Orthosis, Cervical), a Class I device regulated under 21 CFR 890.3490. Orthomedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1981
Date Received
May 11, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Cervical
Device Class
Class I
Regulation Number
890.3490
Review Panel
PM
Submission Type

Other clearances by Orthomedics

  • K832741 — JASON CERVICAL ORTHOSIS (September 20, 1983)
  • K832742 — EXTENSION CONTROL KNEE ORTHOSIS (September 20, 1983)
  • K832740 — FEMORAL FRACTURE ORTHOSIS (September 20, 1983)
  • K811456 — ORTHO-FRAC KIT (June 12, 1981)
  • K811297 — CERVICAL SUPPORT (May 27, 1981)
  • K810555 — SCOLIOSIS ORTHOTIC SYSTEM (March 13, 1981)
  • K810557 — HIP ABDUCTION SPLINT (March 13, 1981)
  • K810556 — SPINAL EXTENSION BRACE (March 13, 1981)
  • K810554 — LUMBAR FLEXION BRACE (March 13, 1981)
  • K803033 — CRUSADER HYPEREXTENSION BRACE (December 22, 1980)

Other clearances for product code IQK

  • K930730 — DORMIE NECK SUPPORT SYSTEM (July 22, 1993)
  • K926291 — SCHUL-TEC IMMOBILIZER (March 30, 1993)
  • K896042 — MEDICAL DISPOSABLE BEDDING (January 10, 1990)
  • K895477 — NOVA PILLOW (January 10, 1990)
  • K882264 — BATTLE CREEK PILLOW (August 9, 1988)
  • K850465 — CERVICAL COLLARS & HEAD HALTERS (April 25, 1985)
  • K832990 — STIFNICK IMMOBILIZING COLLAR (November 7, 1983)
  • K832001 — HEAD-IMMOBILIZER (July 12, 1983)
  • K831582 — VARI-SUPPORT NECK POSTURE PILLOW (June 15, 1983)
  • K830348 — VINYL EXTRICATION COLLAR (March 9, 1983)

FDA data resources