FDA.reportPublic FDA data

InFix® Anterior Lumbar System

Primary DI
00889024331358
Brand
InFix® Anterior Lumbar System
Company
ZIMMER SPINE, INC.
Model
1850-0700
Catalog number
1850-0700
Published
2016-06-23
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
MAXIntervertebral fusion device with bone graft, lumbar
MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024331358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024331358008890243313588890243313580889024331358

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)447-3625USBROCustomerService@zimmerbiomet.com
+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
00197157075859ZAVATION INSERTERZavation LLCMAX2026-05-27
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
07613153046202AVS PLStryker CorporationMQP2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMQP2015-09-14
07613153046226AVS PLStryker CorporationMQP2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMQP2015-09-14
07613153046288AVS PLStryker CorporationMQP2015-09-14
07613153046295AVS PLStryker CorporationMQP2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMQP2015-09-14
07613153046318AVS PLStryker CorporationMQP2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMQP2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMQP2015-09-14
07613153046349AVS PLStryker CorporationMQP2015-09-14
07613153046356AVS PLStryker CorporationMAX2015-09-14
07613153046363AVS PLStryker CorporationMAX2015-09-14
07613153046370AVS PLStryker CorporationMQP2015-09-14
07613153046394AVS TLStryker CorporationMQP2015-09-14
07613153046394AVS TLStryker CorporationMAX2015-09-14
07613153046400AVS TLStryker CorporationMAX2015-09-14