LZV · System, Cement Removal Extraction
Orthopedic · 21 CFR 888.4580 · Class 2
Overview
| Product Code | LZV |
|---|---|
| Device Name | System, Cement Removal Extraction |
| Regulation | 21 CFR 888.4580 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
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.
Special Controls
*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.
Cleared Devices (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K021502 | OSCAR, MODEL OE3000 | Orthosonics, Ltd. | Jun 6, 2002 | SESE |
| K961101 | STRYKER CEMENT REMOVAL SYSTEM | Stryker Corp. | Jul 15, 1996 | SESE |
| K930629 | ACRYL-X II SYSTEM | Sonokinetics, Inc. | Jan 21, 1994 | SESE |
| K904156 | ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS | Origin Medsystems, Inc. | Nov 27, 1990 | SESE |
| K904180 | PROSTHETIC CEMENT REMOVER | Origin Medsystems, Inc. | Nov 20, 1990 | SESE |
| K891472 | IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR | Implant Technology, Inc. | May 2, 1989 | SESE |
| K890285 | PROSTHETIC CEMENT REMOVER | Albert K. Chin | Apr 19, 1989 | SESE |
Top Applicants
- Origin Medsystems, Inc. — 2 clearances
- Stryker Corp. — 1 clearance
- Sonokinetics, Inc. — 1 clearance
- Orthosonics, Ltd. — 1 clearance
- Implant Technology, Inc. — 1 clearance
