FDA.reportPublic FDA data

NA

Primary DI
10705034500935
Brand
NA
Company
DEPUY SPINE, LLC
Model
698343502
Catalog number
698343502
Device description
MODIFIED INSTRUMENT FLEXIBLE DRIVER X15
Published
2019-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXSCREWDRIVER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034500935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503450093510705034500935

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
107105876
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034471716N/A6983411716983411712022-10-07
10705034570105N\A6983447336983447332022-10-07
10705034570211N/A6983447246983447242022-10-07
10705034570228N\A6983447346983447342022-10-07
10705034570433N/A6983447266983447262022-10-07
10705034570501N\A6983447326983447322022-10-07
10705034570624N/A6983447286983447282022-10-07
10705034570693N\A6983447316983447312022-10-07
10705034570723N/A6983447276983447272022-10-07
10705034458267N/A6983393806983393802022-02-02
10705034137049BENGAL1873011131873011132015-09-24
10705034137056BENGAL1873011141873011142015-09-24
10705034137063BENGAL1873011151873011152015-09-24
10705034137070BENGAL1873011161873011162015-09-24
10705034585321TRIALTIS Spine System5560-12-4560FS5560124560FS2026-05-18
10705034585796TRIALTIS Spine System5560-12-4560S5560124560S2026-05-18
10705034604466TRIALTIS Spine System5560-12-7025CS5560127025CS2026-05-18
10705034359007SPOTLIGHT2829509002829509002016-06-30
10705034217727PIPELINE2871050612871050612019-06-06
10705034217789PIPELINE2871050852871050852019-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150081882Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-10
00199150081899Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-10
00842188132513Tools - ScrewsTrimed, INC.HXX2026-07-09
00842188132520Tools - ScrewsTrimed, INC.HXX2026-07-09
06974940307878endophixSuzhou Endophix Co., Ltd.HXX2026-06-23
008401944961003P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944963773P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944966433P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944969193P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
00889024707726SolidLok®Biomet Orthopedics, LLCHXX2026-06-10
07640221373076PERLA ® TLSpineArt SAHXX2026-05-07
09120125220259Shark Screw® driver aclsurgebright GmbHHXX2026-04-30
08800322708224Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
08800322758175Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
08800322758267Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
08800322758274Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HXX2026-04-21
08806373894213LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373899720LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08809695589973PYXIS 3D Titanium Cervical Cage, CloseGS Medical Co., Ltd.HXX2026-01-28
08806373887789BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
08806373892660BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
04719879398700Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-11-26
07640332475294PERLA ®SpineArt SAHXX2025-11-10
07640332475300PERLA ®SpineArt SAHXX2025-11-10
07640332475317PERLA ®SpineArt SAHXX2025-11-10
08059386744253Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-06
08059386742266Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-05
04719962169132Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-10-31
04719962169224Tandry Orthopedic Manual Surgical InstrumentMICROWARE PRECISION CO., LTD.HXX2025-10-31
09348215164737Turbine X Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10