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
1-21 of 21
Cleared Oct 22, 1990
SHEPPERD LUMBAR DISCECTOMY SYSTEM
K900608 · HRX
Orthopedic · 256d
Cleared Oct 22, 1990
SHEPPERD STRAIGHT AND CURVED NEEDLES
K900609 · HRX
Orthopedic · 256d
Cleared Oct 22, 1990
SHEPPERD CANNULA STILLETTE & OBDURATOR SET
K900610 · HRX
Orthopedic · 256d
Cleared Oct 22, 1990
SHEPPERD DILATATION TUBE SET (GS-501-20-H)
K900611 · HRX
Orthopedic · 256d
Cleared Oct 22, 1990
SHEPPERD TREPHINE SET (GS-501-30-V)
K900612 · HRX
Orthopedic · 256d
Cleared Oct 22, 1990
SHEPPERD SHELTER TUBE COMPLETE & DRILL
K900613 · HRX
Orthopedic · 256d
Cleared Oct 22, 1990
SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V)
K900614 · HRX
Orthopedic · 256d
Cleared Oct 22, 1990
SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE
K900615 · HRX
Orthopedic · 256d
Cleared Oct 22, 1990
SHEPPERD CUTTING FORCEPS
K900616 · HRX
Orthopedic · 256d
Cleared Aug 05, 1987
MODIFIED HUCKSTEP INTRAMEDULLARY NAIL
K871947 · HSB
Orthopedic · 78d
Cleared Jun 23, 1987
MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT
K871956 · KWA
Orthopedic · 34d
Cleared Mar 13, 1987
RING UPM TOTAL HIP REPLACEMENT
K864515 · KWA
Orthopedic · 116d
Cleared Dec 18, 1986
MOORE'S STRAIGHT & THOMPSON'S CURVED STEM PROSTHE.
K864631
Orthopedic · 23d
Cleared Sep 03, 1986
CANNULATED LAG SCREWS
K863119 · HTY
Orthopedic · 20d
Cleared Aug 20, 1986
DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATES
K862945
Orthopedic · 15d
Cleared Nov 15, 1985
A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM
K853709 · HRS
Orthopedic · 72d
Cleared May 23, 1984
HUCKSTEPS STAPLES
K841125
Orthopedic · 69d
Cleared May 27, 1982
ARTHROSCOPES & ASSOCIATED INSTRUMENTS
K821359 · HRX
Orthopedic · 21d
Cleared May 27, 1981
HUCKSTEP INTRAMEDULLARY NAIL
K811017 · KTT
Orthopedic · 42d
Cleared Feb 11, 1980
OXFORD EXTERNAL FIXATION SYSTEM
K800184 · JEC
Orthopedic · 13d
Cleared Jan 21, 1980
LIVERPOOL KNEE PROSTHESIS
K792325 · HRY
Orthopedic · 63d
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