Softgood Products and Splints

FDA 510(k) K803239 · Danek Medical, Inc.

Substantially Equivalent

510(k) numberK803239

Submission

Device name
Softgood Products and Splints
Applicant
Danek Medical, Inc.
Mchenry, IL, US
Received
December 23, 1980
Decision date
January 9, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IPX – Orthosis, Rib Fracture, Soft
Device class
Class I (low risk)
Regulation
21 CFR 890.3490
Specialty
Physical Medicine

Other 510(k)s with product code IPX

510(k)DeviceApplicantDecision
K823662Rib Belt (Universal)IPX · Traditional Warm & Form, Orthopedic Materials12/30/1982SE
K823158Rib Belt (Universal)IPX · Traditional Warm & Form, Orthopedic Materials11/10/1982SE

More from Warm & Form, Orthopedic Materials

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K993855Atlantis Anterior Cervical Plate SystemKWQ · Special 12/15/1999SE
K991528Modification to Tenor Spinal System-Rod/Bolt ConnectorMNH · Special 05/28/1999SE
K990603Modification of the Zplate-Atl Anterior Fixation SystemKWQ · Special 03/10/1999SE
K982875Modification to Zplate-Atl Anterior Fixation SystemKWQ · Special 01/19/1999SE
K984522Modification of TSRH Spinal SystemMNI · Special 01/06/1999SE
K982154Modification of Townley Pedicle Screw Plating SystemMNI · Special 07/13/1998SE
K970599Townley Pedicle Screw Plating SystemMNI · Traditional 03/20/1998SE
K943827Spine FixationMNH · Traditional 02/14/1996SN

Questions and answers

When was Softgood Products and Splints cleared by the FDA?

Softgood Products and Splints (K803239) received a 510(k) decision of Substantially Equivalent on January 9, 1981, 17 days after the submission was received.

What is the product code of K803239?

The FDA product code is IPX – Orthosis, Rib Fracture, Soft, a Class I (low risk) device regulated under 21 CFR 890.3490.