Medical Device Manufacturer · US , Memphis , TN

Fournitures Hospitalieres Industrie - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 2002
24
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fournitures Hospitalieres Industrie Orthopedic
23 devices
1-23 of 23
Cleared Jan 23, 2018
ARROW Reverse Porous Glenoid
K171789 · PHX
Orthopedic · 222d
Cleared Sep 14, 2017
BePOD® Foot Screws
K163148 · HWC
Orthopedic · 309d
Cleared Sep 08, 2017
BePOD® EZ Weil Screws
K163710 · HWC
Orthopedic · 252d
Cleared Apr 10, 2017
ARROW Anatomical Porous glenoid
K162068 · MBF
Orthopedic · 258d
Cleared Apr 04, 2017
BePOD Cannulated Arthrodesis Screws
K170040 · HWC
Orthopedic · 89d
Cleared Oct 29, 2015
ARROW Humeral stems size 6 and 16
K150568 · PHX
Orthopedic · 237d
Cleared May 22, 2015
CalcaNail Orthopedic Nail
K150463 · HSB
Orthopedic · 88d
Cleared May 22, 2015
CalcaNail Orthopedic Arthrodesis Nail
K150471 · HSB
Orthopedic · 88d
Cleared Mar 20, 2015
ARROW Reverse Shoulder long keel and short keel glenoid base
K142778 · PHX
Orthopedic · 175d
Cleared Mar 05, 2013
COLS® FIXATION SYSTEM
K120740 · MBI
Orthopedic · 358d
Cleared Jul 12, 2012
ARROW REVERSE SHOULDER SYSTEM
K112193 · PHX
Orthopedic · 349d
Cleared Dec 22, 2011
COLS PEEK
K113591 · HWC
Orthopedic · 17d
Cleared Nov 24, 2010
ARROW ANATOMICAL SHOULDER SYSTEM
K093599 · KWS
Orthopedic · 369d
Cleared Jul 01, 2008
TLS FIXATION SYSTEM
K080974 · HWC
Orthopedic · 88d
Cleared Jun 14, 2007
CANNULATED SCREW
K070617 · HWC
Orthopedic · 101d
Cleared Aug 22, 2005
MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL
K052058 · HSB
Orthopedic · 24d
Cleared May 11, 2005
ALUMINA HEAD
K050556 · LZO
Orthopedic · 69d
Cleared Nov 17, 2004
ALUMINA HEAD
K042035 · LZO
Orthopedic · 111d
Cleared Oct 07, 2004
TITANIUM TELEGRAPH HUMERAL NAIL
K042332 · HSB
Orthopedic · 38d
Cleared Aug 25, 2004
SNAP-OFF SCREWS
K041456 · HWC
Orthopedic · 85d
Cleared Jun 24, 2004
BIO-EUROLIG INTERFERENCE SCREW
K031939 · HWC
Orthopedic · 367d
Cleared Dec 03, 2003
MODIFICATION TO TELEGRAPH HUMERAL NAIL
K033510 · HSB
Orthopedic · 27d
Cleared Dec 24, 2002
TELEGRAPH HUMERAL NAIL
K023241 · HSB
Orthopedic · 85d
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