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510(k) K954645

Device
TITANIUM GDLH POSTERIOR SPINAL SYSTEM
Applicant
SOFAMOR DANEK USA,INC.
510(k) number
K954645
Product code
KWP  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1996-01-16
Date received
1995-10-10
Regulation
888.3050
Classification name
Appliance, Fixation, Spinal Interlaminal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RICHARD W TREHARNE
Address
1800 Pyramid Pl. Memphis TN US 38132 38132

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KWP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.2015-07-29
K150753OASYS SystemStryker Corporation2015-06-09
K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.2015-06-04
K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC2015-04-29
K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2015-04-28
K142253SOLSTICE OCT SystemLife Spine, Inc.2015-04-23
K150229SOLSTICE OCT SystemLife Spine, Inc.2015-04-07
K143249SOLSTICE OCT SystemLife Spine, Inc.2015-04-07
K142741OASYS SystemStryker Corporation2015-01-15
K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m2014-12-22
K140734NEXTGEN ALTIUS OCT SYSTEMEbi, LLC2014-12-15
K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson2014-10-01
K141897SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEMSynthes USA Products, LLC2014-09-25
K141284CASPIAN SPINAL SYSTEMK2m, Inc.2014-07-23
K133288CASPIAN OCT SPINAL SYSTEMK2m, Inc.2014-07-01

Legacy Summary#

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FDA Review#

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