Medical Device Manufacturer · US , Albuquerque, , NM

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

13 submissions · 13 cleared · Since 2001

13

Total

13

Cleared

0

Denied

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

6 devices

1-6 of 6

Cleared Dec 14, 2004

OPUS MINIMAGNUM ANCHOR WITH INSERTER

Orthopedic · 83d

Cleared Nov 12, 2004

OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE

Orthopedic · 22d

Cleared Jun 25, 2004

OPUS MAGNUM ANCHOR WITH INSERTER

Orthopedic · 24d

Cleared Jun 12, 2003

OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500

Orthopedic · 69d

Cleared Jul 22, 2002

OPUS MAGNUM ANCHOR & INSTRUMENT SET

Orthopedic · 186d

Cleared Sep 17, 2001

OPUS MAGNUM ANCHOR & INSERTER

Orthopedic · 73d