FDA.reportPublic FDA data

DURANGO STAND-ALONE ALIF SYSTEM

Primary DI
00888480557081
Brand
DURANGO STAND-ALONE ALIF SYSTEM
Company
BIOMET SPINE LLC
Model
8511-0718
Catalog number
8511-0718
Published
2015-10-24
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
MAXIntervertebral fusion device with bone graft, lumbar
MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE
ODPIntervertebral fusion device with bone graft, cervical
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888480557081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888480557081008884805570818884805570810888480557081

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric 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 non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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
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

Regulatory Flags#

DUNS number
018577570
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304860544Vitality®+ Osteotomy732M2129732M21292018-06-05
00880304860551Vitality®+ Osteotomy732M2221732M22212018-06-05
00880304860568Vitality®+ Osteotomy732M2224732M22242018-06-05
00880304860575Vitality®+ Osteotomy732M2226732M22262018-06-05
00880304860582Vitality®+ Osteotomy732M2229732M22292018-06-05
00888480489450LINEUM OCT SPINE SYSTEM14-52501314-5250132020-10-15
00888480511564LINEUM OCT SPINE SYSTEM14-52505414-5250542020-07-07
00888480207542POLARIS 5.5 SPINAL SYSTEM2000-23252000-23252015-10-24
00880304964143Polaris™ 6.35 Spinal System14-513730R14-513730R2020-11-10
00880304964433Polaris™ 6.35 Spinal System14-513555R14-513555R2020-11-10
03662663058155Spine System14-50077114-5007712021-12-17
03662663058162Spine System14-50077214-5007722021-12-17
03662663058179Spine System14-50077314-5007732021-12-17
03662663058186Spine System14-50077414-5007742021-12-17
03662663058193Spine System14-50077514-5007752021-12-17
03662663058209Spine System14-50077614-5007762021-12-17
03662663058216Spine System14-50077714-5007772021-12-17
03662663058223Spine System14-50077814-5007782021-12-17
03662663058230Spine System14-50077914-5007792021-12-17
03662663058247Spine System14-50078014-5007802021-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.MAX2026-10-01
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.OVD2026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.ODP2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCOVD2018-04-16
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMQP2018-04-16
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMAX2018-04-16
10888857160460CASCADIA™ Interbody SystemVB Spine LLCODP2018-04-16
10888857161061CASCADIA™ Interbody SystemVB Spine LLCMQP2016-09-02
10888857161061CASCADIA™ Interbody SystemVB Spine LLCODP2016-09-02
10888857161061CASCADIA™ Interbody SystemVB Spine LLCMAX2016-09-02
10888857161061CASCADIA™ Interbody SystemVB Spine LLCOVD2016-09-02
10888857161078CASCADIA™ Interbody SystemVB Spine LLCODP2016-09-02
10888857161078CASCADIA™ Interbody SystemVB Spine LLCOVD2016-09-02
10888857161078CASCADIA™ Interbody SystemVB Spine LLCMQP2016-09-02
10888857161078CASCADIA™ Interbody SystemVB Spine LLCMAX2016-09-02
10888857161085CASCADIA™ Interbody SystemVB Spine LLCOVD2016-09-02
10888857161085CASCADIA™ Interbody SystemVB Spine LLCODP2016-09-02
10888857161085CASCADIA™ Interbody SystemVB Spine LLCMAX2016-09-02
10888857161085CASCADIA™ Interbody SystemVB Spine LLCMQP2016-09-02
10888857161092CASCADIA™ Interbody SystemVB Spine LLCMQP2016-09-02
10888857160347CASCADIA™ Interbody SystemVB Spine LLCOVD2015-09-30
10888857160347CASCADIA™ Interbody SystemVB Spine LLCMAX2015-09-30
10888857160347CASCADIA™ Interbody SystemVB Spine LLCODP2015-09-30
10888857160347CASCADIA™ Interbody SystemVB Spine LLCMQP2015-09-30
10888857160354CASCADIA™ Interbody SystemVB Spine LLCODP2015-09-30
10888857160354CASCADIA™ Interbody SystemVB Spine LLCMAX2015-09-30
10888857160354CASCADIA™ Interbody SystemVB Spine LLCMQP2015-09-30
10888857160354CASCADIA™ Interbody SystemVB Spine LLCOVD2015-09-30
10888857160361CASCADIA™ Interbody SystemVB Spine LLCODP2015-09-30
10888857160361CASCADIA™ Interbody SystemVB Spine LLCMQP2015-09-30