FDA.reportPublic FDA data

Titan Inserter

Primary DI
00763000402594
Brand
Titan Inserter
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0420002
Device description
INSERTER X0420002 ENDO TO INSERTER
Published
2020-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWRDRIVER, PROSTHESIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWRDriver, ProsthesisOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083714000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083714000ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)Titan Spine, LLC2009-04-15MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000402594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000402594007630004025947630004025940763000402594

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150076451Medtronic Reusable InstrumentsX36902502026-10-19
00199150080373Medtronic Reusable InstrumentsX02260452026-10-19
00199150080380Medtronic Reusable InstrumentsX02260462026-10-19
00199150080397Medtronic Reusable InstrumentsX02260472026-10-19
00199150080403Medtronic Reusable InstrumentsX02260502026-10-19
00824846003922Medtronic Reusable InstrumentsEX06260022026-10-19
00824846013082Medtronic Reusable InstrumentsX09074302026-10-19
00824846013600Medtronic Reusable InstrumentsX07260042026-10-19
00763000750053CD HORIZON® Fenestrated Screw Spinal System557510245402026-10-16
00763000750251CD HORIZON® Fenestrated Screw Spinal System557510255302026-10-16
00763000750268CD HORIZON® Fenestrated Screw Spinal System557510255352026-10-16
00763000750275CD HORIZON® Fenestrated Screw Spinal System557510255402026-10-16
00763000750374CD HORIZON® Fenestrated Screw Spinal System557510265352026-10-16
00763000750404CD HORIZON® Fenestrated Screw Spinal System557510265502026-10-16
00824846010739Medtronic Reusable InstrumentsX06260032026-10-18
00824846013495Medtronic Reusable InstrumentsEX07260062026-10-18
00763000786458CD HORIZON® Fenestrated Screw Spinal System65411012026-10-15
00643169236967n/a74806532026-10-11
00643169236974n/a74806522026-10-11
00643169236981n/a74806512026-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024715196T6 Driver 127mm AO QCZimmer, Inc.HWR2026-10-19
00889024715202T8 Driver 127mm AO QCZimmer, Inc.HWR2026-10-19
10705034579955N/AMedos International SàrlHWR2026-10-06
00889024712904RMR LONG KEYZimmer, Inc.HWR2026-08-25
00889024712911X BAR RMR ADPT TALLZimmer, Inc.HWR2026-08-25
00889024712928RMR SHORT KEYZimmer, Inc.HWR2026-08-25
00889024712935RMR SHORT KEY BENTZimmer, Inc.HWR2026-08-25
00889024712942RMR LONG KEY BENTZimmer, Inc.HWR2026-08-25
03701089545358AMPLITUDEAMPLITUDE SASHWR2026-07-29
03701089545365AMPLITUDEAMPLITUDE SASHWR2026-07-29
08809926260299InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260312InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260329InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260336InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260343InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260350InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260367InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260374InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260381InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260398InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260404InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
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07640332478462SCARLET® AC-TiSpineArt SAHWR2025-11-10
10603295559436INHANCE INTACTDEPUY (IRELAND)HWR2025-06-13
10603295551768INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-03-07
10603295551805INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-02-21
10603295560050INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-02-21
00810112597967DynaForceCROSSROADS EXTREMITY SYSTEMSHWR2024-08-07
00810112597950MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHWR2024-08-01
G079C5080000040MIS Golden Isles Pedicle Screw System Intelivation, LLCHWR2023-10-03