Panels › General, Plastic Surgery › Product code LXI · Class 1
Guide, Drill, Ligament
Regulation 878.4820
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LXI
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corp | 1 | 0 |
| Dyonics, Inc. | 1 | 0 |
| Instrument Makar, Inc. | 1 | 0 |
| Medmetric Corp. | 1 | 0 |
| Pfizer, Inc. | 1 | 0 |
| Physio Systems, Inc. | 1 | 0 |
| Silent Call Corp. | 1 | 0 |
| Synvasive Technology, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 7, 1994 | K930573 | SYNVASIVE CERAMIC SUTTING BLOCK Synvasive Technology, Inc. | LXI |
| May 21, 1991 | K910712 | VILLAN (VIDEO LIFT LINK ANALYSIS) Physio Systems, Inc. | LXI |
| Sep 28, 1989 | K892655 | ACL DRILL GUIDE SYSTEM Baxter Healthcare Corp | LXI |
| May 19, 1989 | K890445 | PERSONAL ALERT ASSIST DEVICE Silent Call Corp. | LXI |
| Sep 6, 1988 | K882407 | BOW & ARROW DRILL GUIDE Instrument Makar, Inc. | LXI |
| Jun 17, 1988 | K881378 | PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE Pfizer, Inc. | LXI |
| Mar 21, 1988 | K880739 | DYONICS DRILL GUIDE/ISOMETER SYSTEM Dyonics, Inc. | LXI |
| Nov 15, 1985 | K854254 | TENSION-ISOMETER Medmetric Corp. | LXI |
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