LXI · Class I · 21 CFR 878.4820

FDA Product Code LXI: Guide, Drill, Ligament

Leading manufacturers include Medmetric Corp., Dyonics, Inc. and Pfizer, 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 Apr 07, 1994
SYNVASIVE CERAMIC SUTTING BLOCK
K930573
Synvasive Technology, Inc.
Orthopedic · 427d
Cleared May 21, 1991
VILLAN (VIDEO LIFT LINK ANALYSIS)
K910712
Physio Systems, Inc.
Orthopedic · 90d
Cleared Sep 28, 1989
ACL DRILL GUIDE SYSTEM
K892655
Baxter Healthcare Corp
Orthopedic · 168d
Cleared May 19, 1989
PERSONAL ALERT ASSIST DEVICE
K890445
Silent Call Corp.
Orthopedic · 112d
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
Cleared Nov 15, 1985
TENSION-ISOMETER
K854254
Medmetric Corp.
Orthopedic · 24d

About Product Code LXI - Regulatory Context