Femoral Hemi-Hip Prosthesis

FDA 510(k) K862460 · Orthopaedic Device Corp.

Substantially Equivalent

510(k) numberK862460

Submission

Device name
Femoral Hemi-Hip Prosthesis
Applicant
Orthopaedic Device Corp.
Paterson, NJ, US
Received
June 30, 1986
Decision date
October 6, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3390
Specialty
Orthopedic
Implant
Yes

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More from Theken Companies, LLC

510(k)DeviceDecision
K870234P.T.H. Metal-Backed Acetabular CupJDL · Traditional 03/20/1987SE
K863343Superfixation(Tm)KTT · Traditional 09/15/1986SE
K855228Femoral Hemi-Hip ProsthesesKWL · Traditional 02/11/1986SE

Questions and answers

When was Femoral Hemi-Hip Prosthesis cleared by the FDA?

Femoral Hemi-Hip Prosthesis (K862460) received a 510(k) decision of Substantially Equivalent on October 6, 1986, 98 days after the submission was received.

What is the product code of K862460?

The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.