Home / 510(k) Clearances / K831044

510(k) K831044

LIMITED MOTION FUNCTIONAL KNEE BRACE by Orthopedic Systems, Inc. — Product Code ITQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1983
Date Received
March 31, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Joint, Knee, External Brace
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Orthopedic Systems, Inc.

  • K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (January 22, 1996)
  • K920256 — SPINE MOTION ANALYZER WITH EMG (August 10, 1992)
  • K910736 — JACKSON MULTIPURPOSE OPERATING TABLE (May 21, 1991)
  • K910031 — PARK CITY SHOULDER POSITIONER (January 24, 1991)
  • K903938 — C FIT CUP (January 4, 1991)
  • K892503 — NUFFIELD TOTAL KNEE (May 4, 1990)
  • K896678 — SILICONE PLUG (January 30, 1990)
  • K894283 — COMPREHENSIVE SPINE MOTION ANALYZER (January 19, 1990)
  • K890331 — FREEMAN TOTAL HIP SYSTEM RIDGED STEM (October 13, 1989)
  • K890498 — FREEMAN MODULAR HIP STEM RIDGED VERSION (October 13, 1989)

Other clearances for product code ITQ

  • K831310 — BRACE C.T. (May 16, 1983)
  • K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL) (December 30, 1982)
  • K823397 — ANATOMIC FRACTURE BRACE (November 29, 1982)
  • K823159 — DELUXE KNEE IMMOBILIZER (November 10, 1982)
  • K812423 — NEOPRENE KNEE SUPPORT (September 14, 1981)
  • K812094 — AIRCAST PNEUMATIC KNEE BRACE (August 13, 1981)
  • K811689 — CYLINDER KNEE CAST/SPLINT (June 25, 1981)
  • K810222 — LIMB ORHTOSIS (February 4, 1981)
  • K802673 — KNEE BRACE/STABILIZER (November 12, 1980)
  • K780892 — FRACTURE BRACING (June 13, 1978)