PARKE-DAVIS TOTAL KNEE PROSTHESIS
Device Facts
| Record ID | K800363 |
|---|---|
| Device Name | PARKE-DAVIS TOTAL KNEE PROSTHESIS |
| Applicant | Warner-Lambert Co. |
| Product Code | KTZ · Orthopedic |
| Decision Date | Mar 10, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.4150 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.