LXI
8 FDA 510(k) clearances · Product code
90 daysmedian time to decision
427 days90th percentile
8clearances measured
FDA profile
- Official device name
- Guide, Drill, Ligament
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2004: 11 · 2006: 6 · 2007: 14 · 2008: 4 · 2009: 11 · 2010: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SYNVASIVE CERAMIC SUTTING BLOCK (K930573) | Synvasive Technology, Inc. | 1994-04-07 |
| VILLAN (VIDEO LIFT LINK ANALYSIS) (K910712) | Physio Systems, Inc. | 1991-05-21 |
| ACL DRILL GUIDE SYSTEM (K892655) | Baxter Healthcare Corp | 1989-09-28 |
| PERSONAL ALERT ASSIST DEVICE (K890445) | Silent Call Corp. | 1989-05-19 |
| BOW & ARROW DRILL GUIDE (K882407) | Instrument Makar, Inc. | 1988-09-06 |
| PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE (K881378) | Pfizer, Inc. | 1988-06-17 |
| DYONICS DRILL GUIDE/ISOMETER SYSTEM (K880739) | Dyonics, Inc. | 1988-03-21 |
| TENSION-ISOMETER (K854254) | Medmetric Corp. | 1985-11-15 |
Track LXI automatically
Every clearance here is in the API, with alerts when new ones post.