Acu Med, Inc.

FDA Regulatory Profile

Acu Med, Inc. appears in FDA public data with 0 recalls, 43 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on July 17, 2002.

Summary

Total Recalls
0
510(k) Clearances
43
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K021321WRIST FUSION PLATEJuly 17, 2002
K013616POLARUS CAP SCREWDecember 19, 2001
K012655CONGRUENT BONE PLATE SYSTEMNovember 7, 2001
K992525ACUMED MODULAR SHOULDER SYSTEMFebruary 4, 2000
K993657ACUMED SUTURE ANCHORJanuary 13, 2000
K980103ACUMED SUTURE ANCHORMarch 16, 1998
K965028ACUMED SUTURE WASHERMarch 17, 1997
K965029STABLELOC II EXTERNAL FIXATORFebruary 19, 1997
K964500ACUMED TENSION BAND PINDecember 9, 1996
K963026TBDOctober 28, 1996
K963118EXTREMITY BONE SCREWOctober 10, 1996
K963077TBDOctober 1, 1996
K962091POLARUS AF RODJuly 24, 1996
K960711ACUMED BONE GRAFT SYSTEMMay 7, 1996
K954148SUTURE WASHERJanuary 17, 1996
K952330EXTERNAL FIXATOROctober 5, 1995
K951740INTRAMEDULARY FIXATION RODAugust 11, 1995
K950864GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)July 31, 1995
K943855BONE FIXATION NAILJuly 12, 1995
K943856FIXATION PINS/WIRESJuly 6, 1995