Medical Device Manufacturer · US , Washington, Dc , DC

Disc-O-Tech Medical Technologies, Ltd. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2001

Recent clearances: MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE), METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS, CONFIDENCE FENESTRATED INTRODUCER NEEDLE

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Disc-O-Tech Medical Technologies, Ltd. Orthopedic ✕

16 devices

1-12 of 16

Cleared Dec 21, 2007

MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)

Orthopedic · 219d

Cleared Dec 17, 2007

METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS

Orthopedic · 181d

Cleared Nov 03, 2006

CONFIDENCE FENESTRATED INTRODUCER NEEDLE

Orthopedic · 28d

Cleared Sep 14, 2006

CONFIDENCE EX HIGH VISCOSITY BONE CEMENT

Orthopedic · 27d

Cleared Jun 21, 2006

CONFIDENCE HIGH VISCOSITY BONE CEMENT

Orthopedic · 135d

Cleared Jun 17, 2004

SKY BONE EXPANDER SYSTEM (SKY SYSTEM)

Orthopedic · 101d

Cleared May 12, 2004

SKY BONE EXPANDER SYSTEM (SKY SYSTEM)

Orthopedic · 30d

Cleared Mar 26, 2004

FIXION HIP SYSTEM

Orthopedic · 205d

Cleared Jan 28, 2004

SKY BONE EXPANDER SYSTEM

Orthopedic · 30d

Cleared Dec 17, 2003

B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)

Orthopedic · 140d

Cleared May 30, 2003

FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)

Orthopedic · 63d

Cleared Mar 08, 2002

FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)

Orthopedic · 88d