FDA.reportPublic FDA data

UniVise

Primary DI
07613327065657
Brand
UniVise
Company
Stryker Corporation
Model
48590040
Catalog number
48590040
Device description
SPINOUS PROCESS FIXATION PLATE
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
PEKSpinous process plate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
PEKSpinous Process PlateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122509000
K132968000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122509000VERTIFLEX SPINOUS PROCESS FIXATION PLATEVertiflex, Inc.2012-12-17KWP
K132968000UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)Stryker Spine2013-11-18PEK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327065657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327065657076133270656577613327065657

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar interspinous decompression spacer, sterileA sterile device intended to be implanted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient with symptomatic degenerative lumbar spinal stenosis (DLSS). It is typically designed as a small spacer, either a single-piece or assembly, made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and/or synthetic polymer [e.g., hydrogel, polyetheretherketone (PEEK)]. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
149183167
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252254430VertaPlex04066220000406-622-0002016-09-23
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
07613327141771SpinePlex040622200004062220002016-09-23
07613327141788SpinePlex04062020100406-202-0102016-09-23

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Primary DI, Brand, Company table
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