21 CFR 888.4580 — Instrument, Surgical, Sonic And Accessory/Attachment
Orthopedic (OR) · Part 888 Subpart E—Surgical Devices · § 888.4580
Identification
A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.
Classification Rationale
Class II (special 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 |
|---|---|---|---|---|
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | 2 | 23 | |
| LZV | System, Cement Removal Extraction | 2 | 7 |
Special Controls
JDX — Instrument, Surgical, Sonic And Accessory/Attachment
*Classification.* Class II (special 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.
eCFR
LZV — System, Cement Removal Extraction
*Classification.* Class II (special 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.
eCFR
