FDA.reportPublic FDA data

BP® Lordotic

Primary DI
00889024338616
Brand
BP® Lordotic
Company
ZIMMER SPINE, INC.
Model
8002-2128-00
Published
2015-09-24
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
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024338616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024338616008890243386168890243386160889024338616

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28Millimeter
Outer Diameter21Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
787663400
Device count
1
Lot or batch
true
Expiration date on label
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810166522366X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
00810166522373X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
B70712535005S0Dual X Graft Tamp ShortAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010130DUALXS T/PLIF 15 DEG x 9-12MMAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010200DUALXS T/PLIF 18 DEG x 10-13MMAMPLIFY SURGICAL, INC.MAX2026-05-27
07613153046196AVS PLStryker CorporationMAX2015-09-14
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