Medical Device Manufacturer · US , Beaverton , OR

Acu Med, Inc. - FDA 510(k) Cleared Devices

48 submissions · 39 cleared · Since 1990

Recent clearances: WRIST FUSION PLATE, POLARUS CAP SCREW, CONGRUENT BONE PLATE SYSTEM

48

Total

39

Cleared

0

Denied

FDA 510(k) Regulatory Record - Acu Med, Inc. Orthopedic ✕

46 devices

1-12 of 46

Cleared Jul 17, 2002

WRIST FUSION PLATE

Orthopedic · 83d

Cleared Dec 19, 2001

POLARUS CAP SCREW

Orthopedic · 44d

Cleared Nov 07, 2001

CONGRUENT BONE PLATE SYSTEM

Orthopedic · 86d

Cleared Feb 04, 2000

ACUMED MODULAR SHOULDER SYSTEM

Orthopedic · 191d

Cleared Jan 13, 2000

ACUMED SUTURE ANCHOR

Orthopedic · 77d

Cleared Mar 16, 1998

ACUMED SUTURE ANCHOR

Orthopedic · 63d

Cleared Mar 17, 1997

ACUMED SUTURE WASHER

Orthopedic · 90d

Cleared Feb 19, 1997

STABLELOC II EXTERNAL FIXATOR

Orthopedic · 64d

Cleared Dec 09, 1996

ACUMED TENSION BAND PIN

Orthopedic · 31d

Cleared Oct 28, 1996

Orthopedic · 84d

Cleared Oct 10, 1996

EXTREMITY BONE SCREW

Orthopedic · 59d

Cleared Oct 01, 1996

Orthopedic · 54d

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