FDA.reportPublic FDA data

Spine System

Primary DI
00887868243714
Brand
Spine System
Company
BIOMET SPINE LLC
Model
LV01432
Catalog number
LV01432
Published
2018-03-07
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
NQPPOSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQPPosterior Metal/Polymer Spinal System, FusionOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868243714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868243714008878682437148878682437140887868243714

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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

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
20763000313344CD Horizon™ Astute™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2020-08-17
20613994170174CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2016-07-08
00613994123732CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123749CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123800CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123824CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123831CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123909CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123916CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123923CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123985CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123992CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994124012CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994124074CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994188540CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-21
00613994197382CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-21
00613994197412CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-21
00613994197429CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-21
00613994197344CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197375CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197719CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197788CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197795CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-20
00613994197726CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-19
00613994197757CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-19
00613994177193CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18
00613994188502CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18
00613994188519CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18
00613994188533CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18
00613994188571CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-08-18