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FDA 510(k) Applications Submitted by Sharyn Orton, Ph.D.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K140106
01/15/2014
S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
Renovis Surgical Technologies, Inc.
K131354
05/10/2013
RENOVIS BIPOLAR HIP SYSTEM
RENOVIS SURGICAL TECHNOLOGIES LLC
K141370
05/27/2014
RENOVIS CEMENTED HIP SYSTEM
Renovis Surgical Technologies, Inc.
K131766
06/17/2013
PLATINUM DRF IMAGING SYSTEM
APELEM-DMS GROUP
K142095
08/01/2014
RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
Renovis Surgical Technologies, Inc.
K122850
09/18/2012
TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES
MEDITECH ADVISORS, LLC
K123829
12/12/2012
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK
PORTABLE THERAPEUTIX, LLC
K131122
04/22/2013
S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
RENOVIS SURGICAL TECHNOLOGIES, LLC
K141676
06/23/2014
RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM
Renovis Surgical Technologies, Inc.
K132312
07/25/2013
RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
RENOVIS SURGICAL TECHNOLOGIES, LLC
K133483
11/13/2013
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE
PORTABLE THERAPEUTIX
K110462
02/17/2011
KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE
KEPLER MEDTEC
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