FDA.reportPublic FDA data

SlimLine®

Primary DI
00889024404335
Brand
SlimLine®
Company
ZIMMER SPINE, INC.
Model
404-4068
Catalog number
404-4068
Published
2019-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024404335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024404335008890244043358890244043350889024404335

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length68Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)774-6368zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
787663400
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024399006SlimLine®403-4072403-40722015-09-25
00889024403741SlimLine®403-4068403-40682019-12-02
00889024403758SlimLine®403-4076403-40762019-12-02
00889024403765SlimLine®403-4080403-40802019-12-02
00889024403772SlimLine®403-4084403-40842019-12-02
00889024403789SlimLine®403-4088403-40882019-12-02
00889024403796SlimLine®403-4092403-40922019-12-02
00889024404083SlimLine®403-4168403-41682019-12-02
00889024404090SlimLine®403-4172403-41722019-12-02
00889024404106SlimLine®403-4176403-41762019-12-02
00889024404113SlimLine®403-4180403-41802019-12-02
00889024404120SlimLine®403-4184403-41842019-12-02
00889024404137SlimLine®403-4188403-41882019-12-02
00889024404144SlimLine®403-4192403-41922019-12-02
00889024404151SlimLine®404-2036404-20362019-11-17
00889024404168SlimLine®404-2040404-20402019-11-17
00889024404175SlimLine®404-2042404-20422019-11-17
00889024404182SlimLine®404-2044404-20442019-11-17
00889024404199SlimLine®404-2046404-20462019-11-17
00889024404205SlimLine®404-2048404-20482019-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613153143758XIA STAINLESS STEELStryker CorporationKWQ2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationKWQ2015-09-14
07613153045670XIA IStryker CorporationKWQ2014-12-08
07613153045700XIA IStryker CorporationKWQ2014-12-08
07613153045724XIA IStryker CorporationKWQ2014-12-08
07613153045731XIA IStryker CorporationKWQ2014-12-08
07613153045748XIA IStryker CorporationKWQ2014-12-08
07613153045755XIA IStryker CorporationKWQ2014-12-08
07613153045762XIA IIStryker CorporationKWQ2014-12-08
07613153045793XIA IIStryker CorporationKWQ2014-12-08
07613153045854XIA IIStryker CorporationKWQ2014-12-08
07613153045878XIA IIStryker CorporationKWQ2014-12-08
07613153045885XIA IIStryker CorporationKWQ2014-12-08
07613153045892XIA IIStryker CorporationKWQ2014-12-08
07613153045908XIA IIStryker CorporationKWQ2014-12-08
07613153045915XIA IIStryker CorporationKWQ2014-12-08
07613153045922XIA IIStryker CorporationKWQ2014-12-08
07613153045939XIA IIStryker CorporationKWQ2014-12-08
07613153045960XIA IIStryker CorporationKWQ2014-12-08
07613153046011XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046028XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046035XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046042XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046059XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046066XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046073XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046103XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046110XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046127XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046134XIA STAINLESS STEELStryker CorporationKWQ2014-12-08