Caliper
The Caliper is a manual measuring instrument used in orthopedic surgery to measure bone dimensions, distances, and implant sizing intraoperatively or in preoperative planning. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket notification required. The product code is KTZ, regulated under 21 CFR 888.4150, in the Orthopedic medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KTZ
- Device Class
- FDA class 1
- Regulation Number
- 888.4150
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K921266 | NK MEDICAL MICROMETER, MODEL MC001 | Jul 14, 1992 | Substantially Equivalent | Nk Biotechnical Engineering Co. |
| K841687 | SKYNDEX ELECTRONIC BODY FAT CALCULA | Jun 28, 1984 | Substantially Equivalent | Caldwell, Justiss & Co., Inc. |
| K831898 | SCOLIMETER | Jul 19, 1983 | Substantially Equivalent | Dr. Micheal A. Sabia |
| K820659 | A CALIPER | Mar 19, 1982 | Substantially Equivalent | Twin City Surgical, Inc. |
| K810116 | ISOROBIC SKINFOLD CALIPER | Feb 04, 1981 | Substantially Equivalent | Fitness Motivation Institute of America |
| K800363 | PARKE-DAVIS TOTAL KNEE PROSTHESIS | Mar 10, 1980 | Substantially Equivalent | Warner-Lambert Co. |
| K760521 | TAPE MEASURE | Nov 12, 1976 | Substantially Equivalent | Mcgaw Laboratories |
FEI Numbers
This FDA classification entry is associated with 194 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 194 registration numbers. Click on an entry to view related FDA registrations.