FDA.reportPublic FDA data

LITe Plate System

Primary DI
07613327066432
Brand
LITe Plate System
Company
Stryker Corporation
Model
49171137
Catalog number
49171137
Device description
1 LEVEL SACRAL PLATE
Published
2015-09-14
Public version status
Update
Distribution status
Not 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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142699000
K150449000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142699000LITe Plate SystemStryker Corporation2014-12-31KWQ
K150449000LITe Plate SystemStryker Corp.2015-03-20KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327066432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327066432076133270664327613327066432

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).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length37Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
149183167
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540434364SpinePlex04062020000406-202-0002016-06-30
07613154599097NA59200002015920-000-2012016-09-23
07613154599103NA59200002025920-000-2022018-09-24
07613154599110NA59200002035920-000-2032018-09-24
07613154599134NA59200002055920-000-2052018-09-24
07613154599141NA59200002065920-000-2062018-09-24
07613154599158NA59200002075920-000-2072018-09-24
07613154599165NA59200002085920-000-2082018-09-24
07613154599172NA59200002095920-000-2092018-09-24
07613154599189NA59200003015920-000-3012018-09-24
07613154599196NA59200003025920-000-3022018-09-24
07613154599202NA59200003035920-000-3032018-09-24
07613154599219NA59200003045920-000-3042018-09-24
07613154599226NA59200003055920-000-3052018-09-24
07613154599233NA59200003065920-000-3062018-09-24
07613154599240NA59200003075920-000-3072018-09-24
07613154615513NA59200003095920-000-3092018-09-24
07613252254430VertaPlex04066220000406-622-0002016-09-23
07613327141771SpinePlex040622200004062220002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840311248421Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248438Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248445Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248452Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248513Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840493422398RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422404RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422411RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422428RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422435RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422442RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422459RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422466RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422473RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422480RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422497RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422503RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422510RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422527RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422534RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422541RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422558RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422565RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422572RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422589RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263066Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263073Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02