Guide, Drill, Ligament
The Ligament Drill Guide (product code LXI) is a surgical instrument used to accurately direct drilling during ligament reconstruction procedures, ensuring correct tunnel placement for graft passage in surgeries such as ACL reconstruction. Regulated under 21 CFR 878.4820 and classified as a Class 1 device subject only to general controls, it falls under the General and Plastic Surgery specialty with review by the Orthopedic (OR) panel. It is not an implant, is not life-sustaining, and is not GMP-exempt.
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Basic Information
- Product Code
- LXI
- Device Class
- FDA class 1
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K930573 | SYNVASIVE CERAMIC SUTTING BLOCK | Apr 07, 1994 | Substantially Equivalent | Synvasive Technology, Inc. |
| K910712 | VILLAN (VIDEO LIFT LINK ANALYSIS) | May 21, 1991 | Substantially Equivalent | Physio Systems, Inc. |
| K892655 | ACL DRILL GUIDE SYSTEM | Sep 28, 1989 | Substantially Equivalent | Baxter Healthcare Corp |
| K890445 | PERSONAL ALERT ASSIST DEVICE | May 19, 1989 | Substantially Equivalent | Silent Call Corp. |
| K882407 | BOW & ARROW DRILL GUIDE | Sep 06, 1988 | Substantially Equivalent | Instrument Makar, Inc. |
| K881378 | PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE | Jun 17, 1988 | Substantially Equivalent | Pfizer, Inc. |
| K880739 | DYONICS DRILL GUIDE/ISOMETER SYSTEM | Mar 21, 1988 | Substantially Equivalent | Dyonics, Inc. |
| K854254 | TENSION-ISOMETER | Nov 15, 1985 | Substantially Equivalent | Medmetric Corp. |
FEI Numbers
This FDA classification entry is associated with 43 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 43 registration numbers. Click on an entry to view related FDA registrations.