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510(k) K770612

SPLINT, BOHLER by Will Ross Co. — Product Code IQI

K770612 is an FDA 510(k) premarket notification submitted by Will Ross Co. for the device "SPLINT, BOHLER". The FDA issued a decision of Substantially Equivalent on April 8, 1977. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475. Will Ross Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1977
Date Received
March 31, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Limb Brace
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Will Ross Co.

  • K780850 — SEARLE NEONATAL OXYGEN PROBE (August 23, 1978)
  • K771561 — DOVER URINE METER (September 7, 1977)
  • K771132 — KENWOOD BIOLOGICAL STEOILIZ. INDICATOR (July 14, 1977)
  • K770607 — TRACTION HARNESS (April 8, 1977)
  • K770611 — PARALLEL BARS (April 8, 1977)
  • K770609 — TABLE, MASSAGE & TREATMHNT, FIXED HEIGHT (April 8, 1977)
  • K770610 — TABLE, TREATMENT & TRACTION, HI-LO (April 8, 1977)
  • K770608 — WALKING AID (April 8, 1977)
  • K770509 — TABLE, MASSAGE AND TREATMENT (April 5, 1977)
  • K770399 — VALVE FOR CLOSED SYS. URINARY DRAINAGE (March 9, 1977)

Other clearances for product code IQI

  • K143458 — Neurosplint (August 13, 2015)
  • K052771 — SENSOR WALK (May 3, 2006)
  • K031576 — SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 (July 31, 2003)
  • K926391 — ACCUFLEX DYNAMIC ELBOW ORTHOSIS (July 22, 1993)
  • K910974 — MCCONNELL SHOULDER BRACE (March 21, 1991)
  • K874502 — GAIT-AID ORTHOPEDIC INSOLE (November 30, 1987)
  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (June 24, 1983)
  • K831615 — DROP FOOT BRACE (June 15, 1983)
  • K823812 — VARIOUS SUPPORTS AND SPLINTS (January 14, 1983)
  • K823113 — BRACE-UP ALL PURPOSE WRIST BAND (November 16, 1982)

FDA data resources