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510(k) K002607

Device
MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS
Applicant
DEPUY ACROMED
510(k) number
K002607
Product code
KWP  
Decision
Substantially Equivalent (SESE)
Decision date
2000-09-12
Date received
2000-08-22
Regulation
888.3050
Classification name
Appliance, Fixation, Spinal Interlaminal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LISA GILMAN
Address
325 Paramount Dr. Raynham MA US 02767 02767

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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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