Medical Device Manufacturer · US , Albuquerque, , NM

Opus Medical, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2001

Total

Cleared

Denied

Opus Medical, Inc. has 13 FDA 510(k) cleared medical devices. Based in Albuquerque,, US.

Historical record: 13 cleared submissions from 2001 to 2004. Primary specialty: Orthopedic.

Browse the FDA 510(k) cleared devices submitted by Opus Medical, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Opus Medical, Inc.

13 devices

1-12 of 13

Cleared Dec 14, 2004

OPUS MINIMAGNUM ANCHOR WITH INSERTER

K042584 · HWC

Orthopedic · 83d

Cleared Nov 12, 2004

OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE

K042914 · MBI

Orthopedic · 22d

Cleared Oct 19, 2004

OPUS SPEEDSTITCH SUTURE DEVICE

K042031 · GAT

General & Plastic Surgery · 83d

Cleared Jun 25, 2004

OPUS MAGNUM ANCHOR WITH INSERTER

K041440 · MBI

Orthopedic · 24d

Cleared Dec 30, 2003

SMARTSTITCH M-CONNECTOR, MODEL OM-8700

K033317 · OCW

Gastroenterology & Urology · 76d

Cleared Jul 28, 2003

REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500

K030170 · OCW

Gastroenterology & Urology · 192d

Cleared Jun 12, 2003

OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500

K031083 · HTY

Orthopedic · 69d

Cleared Apr 23, 2003

F1 DIODE LASER SYSTEM

K030235 · GEX

General & Plastic Surgery · 90d

Cleared Feb 14, 2003

SMARTSTITCH M-CONNECTOR, MODEL OM-8005

K023843 · OCW

Gastroenterology & Urology · 88d

Cleared Sep 06, 2002

SMARTSTITCH SUTURE DEVICE, MODEL OM-8500

K022229 · OCW

Gastroenterology & Urology · 58d

Cleared Jul 22, 2002

OPUS MAGNUM ANCHOR & INSTRUMENT SET

K020172 · MBI

Orthopedic · 186d

Cleared Sep 17, 2001

OPUS MAGNUM ANCHOR & INSERTER

K012125 · HTY

Orthopedic · 73d

Opus Medical, Inc. - FDA 510(k) Cleared Devices

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