LXI · Class I · 21 CFR 878.4820

FDA Product Code LXI: Guide, Drill, Ligament

Leading manufacturers include Instrument Makar, Inc., Baxter Healthcare Corp and Dyonics, Inc..

8
Total
8
Cleared
127d
Avg days
1985
Since

FDA 510(k) Cleared Guide, Drill, Ligament Devices (Product Code LXI)

8 devices
1–8 of 8
Cleared Sep 28, 1989
ACL DRILL GUIDE SYSTEM
K892655
Baxter Healthcare Corp
Orthopedic · 168d
Cleared Sep 06, 1988
BOW & ARROW DRILL GUIDE
K882407
Instrument Makar, Inc.
Orthopedic · 88d
Cleared Jun 17, 1988
PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE
K881378
Pfizer, Inc.
Orthopedic · 77d
Cleared Mar 21, 1988
DYONICS DRILL GUIDE/ISOMETER SYSTEM
K880739
Dyonics, Inc.
Orthopedic · 26d

About Product Code LXI - Regulatory Context