LXI — Guide, Drill, Ligament Class I

FDA Device Classification

Classification Details

Product Code
LXI
Device Class
Class I
Regulation Number
878.4820
Submission Type
Review Panel
OR
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K930573synvasive technologySYNVASIVE CERAMIC SUTTING BLOCKApril 7, 1994
K910712physio systemsVILLAN (VIDEO LIFT LINK ANALYSIS)May 21, 1991
K892655baxter healthcareACL DRILL GUIDE SYSTEMSeptember 28, 1989
K890445silent callPERSONAL ALERT ASSIST DEVICEMay 19, 1989
K882407instrument makarBOW & ARROW DRILL GUIDESeptember 6, 1988
K881378pfizerPFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDEJune 17, 1988
K880739dyonicsDYONICS DRILL GUIDE/ISOMETER SYSTEMMarch 21, 1988
K854254medmetricTENSION-ISOMETERNovember 15, 1985