LXI · Guide, Drill, Ligament
General, Plastic Surgery · 21 CFR 878.4820 · Class 1
Overview
| Product Code | LXI |
|---|---|
| Device Name | Guide, Drill, Ligament |
| Regulation | 21 CFR 878.4820 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
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 § 878.9.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K930573 | SYNVASIVE CERAMIC SUTTING BLOCK | Synvasive Technology, Inc. | Apr 7, 1994 | SESE |
| K910712 | VILLAN (VIDEO LIFT LINK ANALYSIS) | Physio Systems, Inc. | May 21, 1991 | SESE |
| K892655 | ACL DRILL GUIDE SYSTEM | Baxter Healthcare Corp | Sep 28, 1989 | SESE |
| K890445 | PERSONAL ALERT ASSIST DEVICE | Silent Call Corp. | May 19, 1989 | SESE |
| K882407 | BOW & ARROW DRILL GUIDE | Instrument Makar, Inc. | Sep 6, 1988 | SESE |
| K881378 | PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE | Pfizer, Inc. | Jun 17, 1988 | SESE |
| K880739 | DYONICS DRILL GUIDE/ISOMETER SYSTEM | Dyonics, Inc. | Mar 21, 1988 | SESE |
| K854254 | TENSION-ISOMETER | Medmetric Corp. | Nov 15, 1985 | SESE |
Top Applicants
- Baxter Healthcare Corp — 1 clearance
- Dyonics, Inc. — 1 clearance
- Instrument Makar, Inc. — 1 clearance
- Medmetric Corp. — 1 clearance
- Pfizer, Inc. — 1 clearance
