FDA.reportPublic FDA data

ShurFit PLIF Titanium

Primary DI
00840019929394
Brand
ShurFit PLIF Titanium
Company
PRECISION SPINE, INC.
Model
PLIF25-10
Catalog number
PLIF25-10
Device description
PLIF25-10
Published
2019-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080314000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080314000SPINAL USA INTERBODY FUSION DEVICESpinal USA2008-05-13MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019929394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019929394008400199293948400199293940840019929394

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal fusion cage, non-sterileA non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019904650Slimplicity Anterior Cervical Plate SystemACP118ACP1182019-04-11
00840019904667Slimplicity Anterior Cervical Plate SystemACP120ACP1202019-04-11
00840019904674Slimplicity Anterior Cervical Plate SystemACP122ACP1222019-04-11
00840019904681Slimplicity Anterior Cervical Plate SystemACP124ACP1242019-04-11
00840019904698Slimplicity Anterior Cervical Plate SystemACP126ACP1262019-04-11
00840019904704Slimplicity Anterior Cervical Plate SystemACP128ACP1282019-04-11
00815362021446Slimplicity Anterior Cervical Plate System08-902008-90202019-04-01
00815362021453Slimplicity Anterior Cervical Plate System08-902108-90212019-04-01
00815362021460Slimplicity Anterior Cervical Plate System08-902408-90242019-04-01
00815362021477Slimplicity Anterior Cervical Plate System08-902508-90252019-04-01
00815362021484Slimplicity Anterior Cervical Plate System08-902608-90262019-04-01
00815362021729Slimplicity Anterior Cervical Plate System50-001850-00182019-04-01
00815362021088Slimplicity Anterior Cervical Plate System08-011208-01122019-03-29
00815362021118Slimplicity Anterior Cervical Plate System08-011808-01182019-03-29
00815362021125Slimplicity Anterior Cervical Plate System08-012008-01202019-03-29
00815362021132Slimplicity Anterior Cervical Plate System08-012208-01222019-03-29
00815362021149Slimplicity Anterior Cervical Plate System08-012408-01242019-03-29
00815362021156Slimplicity Anterior Cervical Plate System08-012608-01262019-03-29
00815362021163Slimplicity Anterior Cervical Plate System08-012808-01282019-03-29
00815362021170Slimplicity Anterior Cervical Plate System08-022608-02262019-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000704452MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000704537MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000880897MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881153MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881382MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881399MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881405MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000859404CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-18
00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-18
18257200030743CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030767CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030781CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030804CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030828CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030842CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030866CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030880CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030903CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030927CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030965CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031023CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031047CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031061CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031085CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031108CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031122CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031146CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031160CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031184CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031207CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17