21 CFR § 888.4300 Orthopedic Devices

§ 888.4300 Depth gauge for clinical use.

Current through Sep 8, 2026 · Read all of Part 888

(a) Identification. A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.

(b) Classification. 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.

[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]

← § 888.4230 Cement ventilation tube.§ 888.4505 Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation. →