FDA.reportPublic FDA data

Surgical screwdriver, reusable

Definition
A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.
GUDID devices
16,409
Last updated
2026-09-14 22:39:09

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10888857596719Xia® 3VB Spine LLCPRO-1432-012026-05-12
10888857596726Xia® 3VB Spine LLCPRO-1432-022026-05-12
10888857596733Xia® 3VB Spine LLCPRO-1432-032026-05-12
J011302150000tomas®DENTAURUM GmbH & Co.KG302-150-002026-09-04
J011302250000tomas®DENTAURUM GmbH & Co.KG302-250-002026-09-04
00885556820964General InstrumentsSmith & Nephew, Inc.MA3511ND2023-10-27
07613327697209PANGEAStryker GmbHSIT00071952026-08-27
07640139343185BAGUERA C INSTRUMENTATIONSpineArt SACDP-IN 30 01-N2026-08-27
00843210143644Monaco Pedicle Screw SystemAltus Spine, LLC880-10442026-08-24
00889024712904RMR LONG KEYZimmer, Inc.SSI0086902026-08-25
00889024712911X BAR RMR ADPT TALLZimmer, Inc.SSI0086882026-08-25
00889024712928RMR SHORT KEYZimmer, Inc.SSI0086892026-08-25
00889024712935RMR SHORT KEY BENTZimmer, Inc.SSI0086912026-08-25
00889024712942RMR LONG KEY BENTZimmer, Inc.SSI0086922026-08-25
10885862011206NAExactech, Inc.101-30-012022-10-04
10885862011220NAExactech, Inc.101-30-032022-10-04
10885862011251NAExactech, Inc.101-30-062022-10-04
10885862011268NAExactech, Inc.101-30-072022-10-04
10885862011275NAExactech, Inc.101-30-082022-10-04
10885862028952NAExactech, Inc.151-00-232022-09-19
10886982000934NASynthes GmbHE5115-4/22017-02-20
10886982000941NASynthes GmbHE5115-4/32017-02-20
00840481138041LOCATOR Angled AbutmentZest Anchors, LLC026012026-08-21
00840481138058LOCATOR Angled AbutmentZest Anchors, LLC026022026-08-21
B095329646Hintermann SeriesDt Medtech, LLC3296462026-08-21
10885862085726EquinoxeExactech, Inc.315-98-002022-07-28
04260516875462SIC invent Dental Implant SystemsSIC invent AG9512642026-08-18
04260516875479SIC invent Dental Implant SystemsSIC invent AG9512652026-08-18
07290116153032DriverNORIS MEDICAL LTDNMHX36102026-08-18
07290116153049DriverNORIS MEDICAL LTDNMHX36152026-08-18
07290116153056DriverNORIS MEDICAL LTDNMHX36202026-08-18
07290116153063DriverNORIS MEDICAL LTDNMHX36402026-08-18
07332747086904NANobel Biocare AB376772022-07-25
08057717553635BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLScrewdriver – Bioplan2026-08-18
08057717553642BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLExtractor Screwdriver - Bioplan2026-08-18
04099797012637DriverALTATEC GmbHJ5300.00092026-08-17
04099797018868CAMLOG® AdapterALTATEC GmbHK5302.33102026-08-17
04099797018875CAMLOG® AdapterALTATEC GmbHK5302.33112026-08-17
04099797018882CAMLOG® AdapterALTATEC GmbHK5302.38102026-08-17
04099797018899CAMLOG® AdapterALTATEC GmbHK5302.38112026-08-17
04099797018905CAMLOG® AdapterALTATEC GmbHK5302.43102026-08-17
04099797018912CAMLOG® AdapterALTATEC GmbHK5302.43112026-08-17
04099797018929CAMLOG® AdapterALTATEC GmbHK5302.60112026-08-17
04099797021578AdapterALTATEC GmbHP5002.00112026-08-17
04099797021684iSy® Implant Insertion toolALTATEC GmbHP5300.60102026-08-17
04099797021691iSy® Implant Insertion toolALTATEC GmbHP5300.60282026-08-17
04099797021714iSy® Implant Insertion toolALTATEC GmbHP5300.60302026-08-17
04099797021738iSy® Implant Insertion toolALTATEC GmbHP5300.60322026-08-17
04099797021752iSy® HandleALTATEC GmbHP5300.60482026-08-17
04099797021776iSy® HandleALTATEC GmbHP5300.60502026-08-17
04099797021790iSy® DisconnectorALTATEC GmbHP5300.63082026-08-17
04099797021813iSy® DisconnectorALTATEC GmbHP5300.63102026-08-17
04099797021837iSy® DisconnectorALTATEC GmbHP5300.63122026-08-17
04099797021875iSy® Holding keyALTATEC GmbHP5302.00152026-08-17
04099797021899iSy® AdapterALTATEC GmbHP5302.00162026-08-17
04099797021905iSy® Lab screwdriverALTATEC GmbHP5310.60602026-08-17
04099797021912iSy® ScrewdriverALTATEC GmbHP5316.60382026-08-17
04099797021936iSy® ScrewdriverALTATEC GmbHP5316.60402026-08-17
04099797021950iSy® ScrewdriverALTATEC GmbHP5316.60422026-08-17
04099797021974iSy® ScrewdriverALTATEC GmbHP5317.05382026-08-17
04099797021998iSy® ScrewdriverALTATEC GmbHP5317.05402026-08-17
04099797022018iSy® ScrewdriverALTATEC GmbHP5317.05422026-08-17
04099797022032iSy® ScrewdriverALTATEC GmbHP5317.05502026-08-17
04099797022049iSy® ScrewdriverALTATEC GmbHP5317.05522026-08-17
04099797994278CONELOG® DisconnectorALTATEC GmbHC5300.16012026-08-17
04099797994285CONELOG® DisconnectorALTATEC GmbHC5300.16032026-08-17
04099797994292CONELOG® DisconnectorALTATEC GmbHC5300.20012026-08-17
04099797994308CONELOG® DisconnectorALTATEC GmbHC5300.20032026-08-17
04099797994315CONELOG® AdapterALTATEC GmbHC5302.33102026-08-17
04099797994322CONELOG® AdapterALTATEC GmbHC5302.33112026-08-17
04099797994339CONELOG® AdapterALTATEC GmbHC5302.43102026-08-17
04099797994346CONELOG® AdapterALTATEC GmbHC5302.43112026-08-17
04099797994353CONELOG® AdapterALTATEC GmbHC5302.50112026-08-17
04099797996203DriverALTATEC GmbHJ5300.00072026-08-17
04099797996210DriverALTATEC GmbHJ5300.00082026-08-17
04099797996234DriverALTATEC GmbHJ5300.00112026-08-17
04099797996241DriverALTATEC GmbHJ5300.00202026-08-17
04099797996258DriverALTATEC GmbHJ5300.00212026-08-17
04099797996272DriverALTATEC GmbHJ5300.00252026-08-17
04099797996289DriverALTATEC GmbHJ5300.00272026-08-17