FDA.reportPublic FDA data

NA

Primary DI
20763000210216
Brand
NA
Company
MEDTRONIC, INC.
Model
DB-5000
Device description
ACCY KIT DB-5000 STMLOC CLIP ASSEMBLY
Published
2021-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXRCOVER, BURR HOLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXRCover, Burr HoleNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001096000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001096000BURR HOLE COVER, MODEL XXImage-Guided Neurologics, Inc.2000-10-25GXR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000210216PrimaryGS10
00763000210212Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300021021620763000210216
00763000210212007630002102127630002102120763000210212

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbable, non-customizedA small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, cover a burr hole and/or position/stabilize a prosthesis. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be packaged with the plate.

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
5
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150062911N/AAFR-002132026-09-04
00613994733658Pulmonary Wedge Pressure Catheter1500752016-06-12
00613994811639Z2Z26JR4052016-06-11
00613994813053Z2Z26EBU3552016-06-11
00643169356979Z2Z27FR40D2016-04-25
00643169356993Z2Z27AL75D2016-06-11
00643169559820Euphora™EUP1510X2016-04-25
00643169559837Euphora™EUP1512X2016-04-11
00643169559844Euphora™EUP1515X2016-04-11
00643169559851Euphora™EUP1520X2016-04-11
00643169559868Euphora™EUP2006X2016-04-11
00643169559875Euphora™EUP2010X2016-04-11
00643169559905Euphora™EUP2020X2016-04-11
00643169559912Euphora™EUP2025X2016-04-25
00643169559929Euphora™EUP2030X2016-04-11
00643169559936Euphora™EUP22506X2016-04-11
00643169559943Euphora™EUP22510X2016-04-11
00643169559950Euphora™EUP22512X2016-04-11
00643169559967Euphora™EUP22515X2016-04-11
00643169559974Euphora™EUP22520X2016-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327694482DELTAStryker Leibinger GmbH & Co. KGGXR2026-07-21
07613327694499DELTAStryker Leibinger GmbH & Co. KGGXR2026-07-21
08806390889049Leforte Neuro System Bone PlateJeil Medical CorporationGXR2023-11-30
G28436102NuCrani Large PlateNeurovention LLCGXR2022-06-21
08806390888851Leforte Neuro System Bone PlateJeil Medical CorporationGXR2022-05-03
07613327543032DELTAStryker Leibinger GmbH & Co. KGGXR2020-12-15
08809416061542Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061559Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061566Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061573Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061580Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061603Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061627Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061634Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061641Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061658Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061665Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061672Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061733Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809399740946Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399740953Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399745231Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399745248Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399745255Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399745279Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809399745286Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061535Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061689Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061696Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061702Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13