Medical Device Manufacturer · US , Plymouth , MN

Orthomet, Inc. - FDA 510(k) Cleared Devices

60 submissions · 41 cleared · Since 1986
60
Total
41
Cleared
0
Denied
58 devices
26-50 of 58
Cleared Oct 18, 1991
AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERT
K912894 · JWH
Orthopedic · 109d
Cleared May 23, 1991
PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM
K911197 · JWH
Orthopedic · 66d
Cleared May 23, 1991
TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY
K911198 · JWH
Orthopedic · 66d
Cleared Nov 09, 1990
PERFECTA TOTAL HIP SYSTEM
K903635 · JDI
Orthopedic · 88d
Cleared Jul 06, 1990
SECOND GENERATION KNEE SYSTEM, FEMORAL, PATELLAR
K895145 · JWH
Orthopedic · 322d
Cleared Jul 03, 1990
PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP
K901936 · JWH
Orthopedic · 64d
Cleared May 22, 1990
DOMED AND FINNED ACETABULAR COMPONENT
K901328 · JDI
Orthopedic · 62d
Cleared Nov 20, 1989
ORTHOMET PLUS TOTAL KNEE SYST, TITANIUM TIBIAL PEG
K893040 · JWH
Orthopedic · 210d
Cleared Oct 06, 1989
SECOND GENERATION KNEE SYSTEM
K894334 · JWH
Orthopedic · 84d
Cleared Sep 15, 1989
PLUS TOTAL KNEE SYSTEM, (PPD) TIBIAL COMPONENT
K893762 · JWH
Orthopedic · 119d
Cleared May 23, 1989
BIPOLAR HIP SYSTEM
K892398 · KXA
Orthopedic · 46d
Cleared May 10, 1989
INTRAFORM TOTAL HIP SYSTEM
K890742 · JDI
Orthopedic · 86d
Cleared Apr 07, 1989
PERFECTA II/NON-COATED TOTAL HIP SYSTEM
K884027 · JDI
Orthopedic · 196d
Cleared Jan 27, 1989
LEA PLAZA SPINAL FRAME SYSTEM
K884585 · KWP
Orthopedic · 86d
Cleared Dec 28, 1988
PERFECTA II TOTAL HIP SYSTEM
K883618 · JDI
Orthopedic · 126d
Cleared Nov 30, 1988
PROFORMA HIP SYSTEM
K883941 · JDI
Orthopedic · 72d
Cleared Jun 29, 1988
PROFORMA/PS TOTAL HIP SYSTEM
K880435 · JDI
Orthopedic · 148d
Cleared Apr 05, 1988
INTRAFORM TOTAL HIP SYSTEM
K880390 · JDI
Orthopedic · 67d
Cleared Mar 15, 1988
PERFECTA TOTAL HIP SYSTEM
K880461 · JDI
Orthopedic · 41d
Cleared Feb 18, 1988
TOWNLEY COX COMB ACETABULAR CUP
K880004 · JDI
Orthopedic · 45d
Cleared Feb 17, 1988
PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG
K875201 · JWH
Orthopedic · 61d
Cleared Feb 04, 1988
ORTHOMET ORTHOPEDIC STAPLES
K874914 · JDR
Orthopedic · 63d
Cleared Feb 03, 1988
ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS
K874915 · KWL
Orthopedic · 62d
Cleared Jan 14, 1988
ORTHOMET BONE PLATES
K875086 · HRS
Orthopedic · 36d
Cleared Jan 07, 1988
ORTHOMET PIN SYSTEM
K874913 · HTY
Orthopedic · 35d
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