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510(k) K812401

CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O by Surgical Appliance Industries, Inc. — Product Code IPT

K812401 is an FDA 510(k) premarket notification submitted by Surgical Appliance Industries, Inc. for the device "CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O". The FDA issued a decision of Substantially Equivalent on September 14, 1981. The device falls under product code IPT (Orthosis, Thoracic), a Class I device regulated under 21 CFR 890.3490. Surgical Appliance Industries, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1981
Date Received
August 20, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Surgical Appliance Industries, Inc.

  • K121106 — TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION G (April 27, 2012)
  • K821682 — TRUNCAL ORTHOSIS (June 24, 1982)
  • K813416 — EXTERNAL BREAST PROSTHESIS (January 18, 1982)
  • K812423 — NEOPRENE KNEE SUPPORT (September 14, 1981)
  • K812422 — CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS (September 14, 1981)
  • K811689 — CYLINDER KNEE CAST/SPLINT (June 25, 1981)
  • K811690 — ANKLE-FOOT CAST/SPLINT (June 25, 1981)
  • K811494 — LUMBO-SACRAL FLEXION ORTHOSIS (June 16, 1981)

Other clearances for product code IPT

  • K963091 — VOLLMAN PRONE POSITIONER (January 9, 1997)
  • K821645 — BACK SKPPORTS (June 11, 1982)
  • K811750 — MULTITUBULAR THORACIC AIR SPLINTS (July 20, 1981)
  • K761128 — LATERAL TRUNK SUPPORTS (December 2, 1976)

FDA data resources