FDA.reportPublic FDA data

PILLAR TL

Primary DI
18257200041411
Brand
PILLAR TL
Company
Orthofix US LLC
Model
46-1615
Device description
PILLAR TL TRIAL 11X33X15 PARALLEL
Published
2019-03-19
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200041411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720004141118257200041411

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)527-0404customerservice@orthofix.com

Regulatory Flags#

DUNS number
927083808
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18257200066421Orthofix Proview70-23002016-07-14
18257200066438Orthofix Proview70-23012016-07-14
18257200066445Orthofix Proview70-23022016-07-14
18257200066452Orthofix Proview70-23032016-07-14
28257200066497Orthofix Proview70-23042016-07-14
00850071315226TrendDCT-0180DCT-01802026-04-25
00850071315264TrendDCT-3951DCT-39512026-04-25
00850071315295TrendDCT-6061T-2DCT-6061T-22026-04-25
00850071315301TrendDCT-6061T-3DCT-6061T-32026-04-25
00850071315332TrendDCT-6061S-2DCT-6061S-22026-04-25
00850071315356TrendDCT-6061S-4DCT-6061S-42026-04-25
00850071315370TrendDCT-1971-2DCT-1971-22026-04-25
00850071315387TrendDCT-1971-4DCT-1971-42026-04-25
00850071315400TrendDCT-908-RDCT-908-R2026-04-25
00850071315417TrendDCT-908-LDCT-908-L2026-04-25
00850071315448TrendDCT-200-RDCT-200-R2026-04-25
00850071315455TrendDCT-200-LDCT-200-L2026-04-25
00850071315509TrendVSL-747-LGVSL-747-LG2026-04-25
00850071315516TrendDCT-3960DCT-39602026-04-25
00850071315462TrendDCT-1516-RDCT-1516-R2026-04-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49401B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49402B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49403B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49404B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49405B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49406B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49407B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49408B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49409B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49410B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49411B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49412B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49413B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49414B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49415B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49416B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49417B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49418B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500010Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500040Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500050Surgical DirectSurgical Direct, Inc.LXH2026-07-09