Medical Device Manufacturer · US , Mchenry , IL

Downs Surgical , Ltd. - FDA 510(k) Cleared Devices

60 submissions · 60 cleared · Since 1980

60

Total

60

Cleared

0

Denied

FDA 510(k) Regulatory Record - Downs Surgical , Ltd. Orthopedic ✕

21 devices

1-12 of 21

Cleared Oct 22, 1990

SHEPPERD LUMBAR DISCECTOMY SYSTEM

Orthopedic · 256d

Cleared Oct 22, 1990

SHEPPERD STRAIGHT AND CURVED NEEDLES

Orthopedic · 256d

Cleared Oct 22, 1990

SHEPPERD CANNULA STILLETTE & OBDURATOR SET

Orthopedic · 256d

Cleared Oct 22, 1990

SHEPPERD DILATATION TUBE SET (GS-501-20-H)

Orthopedic · 256d

Cleared Oct 22, 1990

SHEPPERD TREPHINE SET (GS-501-30-V)

Orthopedic · 256d

Cleared Oct 22, 1990

SHEPPERD SHELTER TUBE COMPLETE & DRILL

Orthopedic · 256d

Cleared Oct 22, 1990

SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V)

Orthopedic · 256d

Cleared Oct 22, 1990

SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE

Orthopedic · 256d

Cleared Oct 22, 1990

SHEPPERD CUTTING FORCEPS

Orthopedic · 256d

Cleared Aug 05, 1987

MODIFIED HUCKSTEP INTRAMEDULLARY NAIL

Orthopedic · 78d

Cleared Jun 23, 1987

MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT

Orthopedic · 34d

Cleared Mar 13, 1987

RING UPM TOTAL HIP REPLACEMENT

Orthopedic · 116d