Parke-Davis Total Knee Prosthesis
FDA 510(k) K800363 · Warner-Lambert Co.
510(k) numberK800363
Submission
- Device name
- Parke-Davis Total Knee Prosthesis
- Applicant
- Warner-Lambert Co.
Mchenry, IL, US - Received
- February 20, 1980
- Decision date
- March 10, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KTZ – Caliper
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4150
- Specialty
- Orthopedic
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|---|---|---|---|
| K921266 | NK Medical Micrometer, Model MC001KTZ · Traditional | Nk Biotechnical Engineering Co. | 07/14/1992SE |
| K841687 | Skyndex Electronic Body Fat CalculaKTZ · Traditional | Caldwell, Justiss & Co., Inc. | 06/28/1984SE |
| K831898 | ScolimeterKTZ · Traditional | Dr. Micheal A. Sabia | 07/19/1983SE |
| K820659 | A CaliperKTZ · Traditional | Twin City Surgical, Inc. | 03/19/1982SE |
| K810116 | Isorobic Skinfold CaliperKTZ · Traditional | Fitness Motivation Institute of America | 02/04/1981SE |
| K760521 | Tape MeasureKTZ · Traditional | Mcgaw Laboratories | 11/12/1976SE |
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Questions and answers
When was Parke-Davis Total Knee Prosthesis cleared by the FDA?
Parke-Davis Total Knee Prosthesis (K800363) received a 510(k) decision of Substantially Equivalent on March 10, 1980, 19 days after the submission was received.
What is the product code of K800363?
The FDA product code is KTZ – Caliper, a Class I (low risk) device regulated under 21 CFR 888.4150.