Medical Device Manufacturer · US , Martinez , CA

Ace Medical Co. - FDA 510(k) Cleared Devices

21 submissions · 17 cleared · Since 1987
21
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ace Medical Co. Orthopedic
21 devices
1-21 of 21
Cleared Aug 26, 1997
DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL
K972183 · HSB
Orthopedic · 77d
Cleared Apr 01, 1996
ACE HUMERUS & RADIUS PLATES
K955472 · HRS
Orthopedic · 123d
Cleared Jan 31, 1996
ACE-DUPONT COMPOSITE RINGS
K955388 · LXT
Orthopedic · 68d
Cleared Oct 31, 1995
6.5MM SOLID CANCELLOUS BONE SCREW
K954485 · HWC
Orthopedic · 34d
Cleared Oct 12, 1995
ACE CERVICAL TRACTION HALOZS, TONGS & PINS
K954069 · HAX
Orthopedic · 43d
Cleared May 10, 1995
ACE SUPRACONDYLAR PLATE
K950618 · HRS
Orthopedic · 89d
Cleared Jun 16, 1994
ACE PELVIC STABILIZER
K933968 · JEC
Orthopedic · 304d
Cleared Apr 28, 1994
ACE 6.5 MM BONE SCREW
K931652 · HWC
Orthopedic · 388d
Cleared Jul 26, 1993
ACE UNIVERSAL RECONSTRUCTION PLATE
K930592 · HRS
Orthopedic · 172d
Cleared Nov 27, 1991
ACE CORTICAL BONE SCREW
K912598 · HWC
Orthopedic · 170d
Cleared Nov 21, 1991
ACE OPEN-BACK HALO RING
K914858 · JEC
Orthopedic · 23d
Cleared Jul 08, 1991
AIM TIBIAL NAIL
K911554 · HSB
Orthopedic · 90d
Cleared Mar 14, 1991
ACE RECONSTRUCTIVE PLATE
K905595 · HRS
Orthopedic · 91d
Cleared Jan 30, 1991
ACE 3.5MM CORTICAL BONE SCREW
K905048 · HWC
Orthopedic · 83d
Cleared Oct 16, 1990
ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW
K903810 · HWC
Orthopedic · 57d
Cleared Oct 16, 1990
ACE CANNULATED CORTICAL BONE SCREW
K903811 · HWC
Orthopedic · 57d
Cleared Jun 22, 1989
REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW
K892214 · HWC
Orthopedic · 80d
Cleared Jan 20, 1988
ACE INTRA COMPARTMENTAL PRESSURE MONITOR
K873684 · LXC
Orthopedic · 128d
Cleared Nov 24, 1987
ACE SELFTAPPING CANCELLOUS BONE SCREW
K874593 · HWC
Orthopedic · 15d
Cleared Oct 15, 1987
WILLIAMS VERTEBRAL SPREADER
K872858 · HXP
Orthopedic · 86d
Cleared Aug 17, 1987
ACE CANCELLOUS BONE SCREW
K872859 · HWC
Orthopedic · 27d
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