FDA.reportPublic FDA data

510(k) K101704

Device
ZIMMER DTO PIN PRESS INSTRUMENT
Applicant
ZIMMER SPINE, INC.
510(k) number
K101704
Product code
NQP  
Decision
Substantially Equivalent (SESE)
Decision date
2010-08-18
Date received
2010-06-17
Regulation
888.3070
Classification name
Posterior Metal/polymer Spinal System, Fusion
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TIM CRABTREE
Address
7375 Bush Lake Rd. Minneapolis MN US 55439 55439

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NQP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2021-01-15
K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2019-10-03
K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2019-01-11
K133164DYNESYS TOP-LOADING SPINAL SYSTEMZimmer Spine, Inc.2014-01-16
K101083DSS STABILIZATION SYSTEMParadigm Spine, LLC2010-07-02
K092234DYNESYS TOP-LOADING SPINAL SYSTEMZimmer Spine, Inc.2009-10-01
K091944MODIFICATION TO: DSS STABILIZATION SYSTEMParadigm Spine, LLC2009-08-03
K073439TRANSITION STABILIZATION SYSTEMGlobus Medical, Inc.2009-02-20
K080241DDS STABILIZATION SYSTEMParadigm Spine, LLC2008-11-28
K080963DSS STABILIZATION SYSTEMParadigm Spine2008-05-02
K071261ISOBAR SEMI-RIGID DUAL DAMPENERScient'X2008-04-17
K072321BIOFLEXBiospine Co., Ltd.2008-03-25
K073347DYNESYS TOP-LOADING SPINAL SYSTEMZimmer Spine, Inc.2008-02-08
K072969DSSParadigm Spine, LLC2008-01-24
K072685NGARDE SYSTEMN Spine, Inc.2007-10-19

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases