FDA Product Code
FDA Product Code LXI — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4820
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K930573 | SYNVASIVE CERAMIC SUTTING BLOCK | Synvasive Technology, Inc. | 1994-04-07 | Traditional | PDF ↗ |
| K910712 | VILLAN (VIDEO LIFT LINK ANALYSIS) | Physio Systems, Inc. | 1991-05-21 | Traditional | PDF ↗ |
| K892655 | ACL DRILL GUIDE SYSTEM | Baxter Healthcare Corp | 1989-09-28 | Traditional | PDF ↗ |
| K890445 | PERSONAL ALERT ASSIST DEVICE | Silent Call Corp. | 1989-05-19 | Traditional | PDF ↗ |
| K882407 | BOW & ARROW DRILL GUIDE | Instrument Makar, Inc. | 1988-09-06 | Traditional | PDF ↗ |
| K881378 | PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE | Pfizer, Inc. | 1988-06-17 | Traditional | PDF ↗ |
| K880739 | DYONICS DRILL GUIDE/ISOMETER SYSTEM | Dyonics, Inc. | 1988-03-21 | Traditional | PDF ↗ |
| K854254 | TENSION-ISOMETER | Medmetric Corp. | 1985-11-15 | Traditional | PDF ↗ |
Product code LXI · Class I · General, Plastic Surgery. Data: openFDA.