Medical Device Manufacturer · US , Arlington , VA

Biodynamic Technologies, Inc. - FDA 510(k) Cleared Devices

30 submissions · 28 cleared · Since 1985
30
Total
28
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biodynamic Technologies, Inc. Orthopedic
25 devices
1-25 of 25
Cleared Mar 31, 1999
ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM
K990436 · HSB
Orthopedic · 48d
Cleared Mar 17, 1999
ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM
K990481 · HRS
Orthopedic · 29d
Cleared Mar 17, 1999
ULTIMAX CORTICAL BONE SCREWS
K990513 · HWC
Orthopedic · 27d
Cleared Jun 01, 1998
ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
K981230 · HSB
Orthopedic · 59d
Cleared Apr 03, 1998
BTI HUMERAL INTRAMEDULLARY ROD SYSTEM
K980102 · HSB
Orthopedic · 81d
Cleared Mar 12, 1998
BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
K974756 · HWC
Orthopedic · 83d
Cleared Aug 29, 1997
BTI CORTICAL BONE SCREWS
K972403 · HWC
Orthopedic · 64d
Cleared Apr 21, 1997
BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
K970897 · HSB
Orthopedic · 41d
Cleared Nov 13, 1996
EZ-FIX CANNULATED SCREW SYSTEM
K962706 · HWC
Orthopedic · 124d
Cleared Nov 04, 1996
EZ-FIX SMALL CANNULATED SCREW SYSTEM
K962987 · HWC
Orthopedic · 95d
Cleared Oct 23, 1996
EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM
K962846 · LXT
Orthopedic · 93d
Cleared Sep 25, 1996
EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM
K962552 · HSB
Orthopedic · 86d
Cleared Aug 28, 1996
EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM
K962553 · HSB
Orthopedic · 58d
Cleared Jan 24, 1996
EZ FIX
K954838 · JEC
Orthopedic · 96d
Cleared Oct 14, 1994
ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM
K935593 · HSD
Orthopedic · 329d
Cleared Sep 01, 1994
TOTAL KNEE KIT
K932918 · HWE
Orthopedic · 443d
Cleared Mar 22, 1994
BONE CEMENT RESTRICTOR
K926216 · JDK
Orthopedic · 467d
Cleared Mar 09, 1994
FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM
K935646 · JDQ
Orthopedic · 106d
Cleared Jan 27, 1994
UNIVERSAL BONE CEMENT KIT
K931540 · LZN
Orthopedic · 304d
Cleared Feb 12, 1993
THE UNIVERSAL BONE CEMENT RESISTOR
K924323 · JDI
Orthopedic · 169d
Cleared Feb 07, 1992
FX-CABLELOK SYSTEM, MODIFICATION
K915259 · JDQ
Orthopedic · 80d
Cleared Jul 09, 1991
FX-CABLELOK SYSTEM
K912207 · JDQ
Orthopedic · 50d
Cleared May 02, 1986
OSTEOMILL BONE GRINDER
K861164 · LYS
Orthopedic · 35d
Cleared Jul 16, 1985
CEMENTRIFUGE
K851205 · JDZ
Orthopedic · 112d
Cleared Apr 25, 1985
SHOULDER-HOLDER
K851206
Orthopedic · 30d
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