HTH · Protractor
Orthopedic · 21 CFR 888.4600 · Class 1
Overview
| Product Code | HTH |
|---|---|
| Device Name | Protractor |
| Regulation | 21 CFR 888.4600 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
Identification
A protractor for clinical use is a device intended for use in measuring the angles of bones, such as on x-rays or in surgery.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K861576 | SHORTENING OSTEOTOMY GUIDE | Osteotomy Guide Co. | May 12, 1986 | SESE |
| K841470 | REESE OSTEOTOMY GUIDE SYS | Osteotomy Guide Co. | May 23, 1984 | SESE |
| K822305 | ORTHO-LEVEL | Frontier Products | Aug 20, 1982 | SESE |
Top Applicants
- Osteotomy Guide Co. — 2 clearances
- Frontier Products — 1 clearance
