FDA.reportPublic FDA data

Sentry ALIF

Primary DI
00190837091514
Brand
Sentry ALIF
Company
Life Spine, Inc.
Model
2019-0081
Catalog number
2019-0081
Published
2019-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132589000ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO)Life Spine, Inc.2013-10-08KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190837091514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190837091514001908370915141908370915140190837091514

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
183641617
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190837085728ProLift Lateral149-4002149-40022019-11-19
00190837030919Pro Lift Instruments114-204-2114-204-22019-11-07
00190837030926Pro Lift Instruments114-204-3114-204-32019-11-07
00190837030957Pro Lift Instruments151-219151-2192019-11-07
00190837030964Pro Lift Instruments112-222112-2222019-11-07
00190837030988Pro Lift Instruments112-351112-3512019-11-07
00190837030995Pro Lift Instruments129-1006129-10062019-11-07
00190837031008Pro Lift Instruments129-1007129-10072019-11-07
00190837031015Pro Lift Instruments129-1008129-10082019-11-07
00190837031022Pro Lift Instruments129-1009129-10092019-11-07
00190837031039Pro Lift Instruments129-1010129-10102019-11-07
00190837031046Pro Lift Instruments129-1011129-10112019-11-07
00190837031053Pro Lift Instruments129-1012129-10122019-11-07
00190837031060Pro Lift Instruments129-1013129-10132019-11-07
00190837031077Pro Lift Instruments151-262151-2622019-11-07
00190837031084Pro Lift Instruments151-265151-2652019-11-07
00190837031091Pro Lift Instruments151-268151-2682019-11-07
00190837031107Pro Lift Instruments151-271151-2712019-11-07
00190837031121Pro Lift Instruments151-277151-2772019-11-07
00190837031138Pro Lift Instruments151-280151-2802019-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-23
00810017916139SABER-XA, Anterior Plate, 34Wx11HELEVATION SPINE, INC.KWQ2026-10-23
00810017916146SABER-XA, Anterior Plate, 34Wx13HELEVATION SPINE, INC.KWQ2026-10-23
00810017916153SABER-XA, Anterior Plate, 34Wx16HELEVATION SPINE, INC.KWQ2026-10-23
00810017916207SABER-XA, Anterior Plate, 37Wx11HELEVATION SPINE, INC.KWQ2026-10-23
00810017916221SABER-XA, Anterior Plate, 37Wx16HELEVATION SPINE, INC.KWQ2026-10-23
00810017916276SABER-XA, Anterior Plate, 40Wx11HELEVATION SPINE, INC.KWQ2026-10-23
00810017916283SABER-XA, Anterior Plate, 40Wx13HELEVATION SPINE, INC.KWQ2026-10-23
00810017916290SABER-XA, Anterior Plate, 40Wx16HELEVATION SPINE, INC.KWQ2026-10-23
00840466901011PrimusSPINAL ELEMENTS, INC.KWQ2026-10-22
00840606168472SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-10-22
00840606168502SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-10-22
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-15
10889981214289MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214296MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214302MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214319MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214326MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214333MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214340MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214357MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214364MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214371MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214388MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214494MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214500MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214517MeridianSeaspine Orthopedics CorporationKWQ2020-12-30