21 CFR 888.4800 — Template
Orthopedic (OR) · Part 888 Subpart E—Surgical Devices · § 888.4800
Identification
A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HWT | Template | 1 | 10 |
