Home / 510(k) Clearances / K803239

510(k) K803239

SOFTGOOD PRODUCTS AND SPLINTS by Danek Medical, Inc. — Product Code IPX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1981
Date Received
December 23, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Rib Fracture, Soft
Device Class
Class I
Regulation Number
890.3490
Review Panel
PM
Submission Type

Other clearances by Danek Medical, Inc.

  • K994122 — BONE GRAFT WASHER, MODEL 9090114 - 9090118 (February 18, 2000)
  • K993810 — CD HORIZON SPINAL SYSTEM (February 3, 2000)
  • K993855 — ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM (December 15, 1999)
  • K991528 — MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR (May 28, 1999)
  • K990603 — MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM (March 10, 1999)
  • K982875 — MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM (January 19, 1999)
  • K984522 — MODIFICATION OF TSRH SPINAL SYSTEM (January 6, 1999)
  • K982154 — MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM (July 13, 1998)
  • K970599 — TOWNLEY PEDICLE SCREW PLATING SYSTEM (March 20, 1998)
  • K943827 — SPINE FIXATION (February 14, 1996)

Other clearances for product code IPX

  • K823662 — RIB BELT (UNIVERSAL) (December 30, 1982)
  • K823158 — RIB BELT (UNIVERSAL) (November 10, 1982)