Protractor
An orthopedic protractor is a manual measuring instrument used during surgery to measure angles, such as the degree of joint angulation or implant placement orientation. It is classified as an FDA Class 1 device under 21 CFR 888.4600, indicating minimal risk and general controls only. Product code HTH falls under the Orthopedic medical specialty.
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Basic Information
- Product Code
- HTH
- Device Class
- FDA class 1
- Regulation Number
- 888.4600
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K861576 | SHORTENING OSTEOTOMY GUIDE | May 12, 1986 | Substantially Equivalent | Osteotomy Guide Co. |
| K841470 | REESE OSTEOTOMY GUIDE SYS | May 23, 1984 | Substantially Equivalent | Osteotomy Guide Co. |
| K822305 | ORTHO-LEVEL | Aug 20, 1982 | Substantially Equivalent | Frontier Products |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.