FDA.reportPublic FDA data

UNIVERSAL NEURO 3

Primary DI
37613252633595
Brand
UNIVERSAL NEURO 3
Company
Stryker Leibinger GmbH & Co. KG
Model
56-15945S4
Catalog number
56-15945S4
Device description
SCREW, SELF-DRILLING
Published
2015-06-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HBWFASTENER, PLATE, CRANIOPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBWFastener, Plate, CranioplastyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112557000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112557000STRYKER UNIVERSAL NEURO 3 SYSTEMStryker2012-01-05GWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613252633595PrimaryGS10
07613252633594Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761325263359537613252633595
07613252633594076132526335947613252633594

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153956
Device count
4
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
37613327122962NA29-9300329-930032018-04-13
04546540274250NA64-0013264-001322017-01-11
07613327122893NA29-9300129-930012017-12-01
07613327122909NA29-9200129-920012017-03-31
07613327122916NA29-9200329-920032017-03-31
07613327122930NA29-9200229-920022017-03-31
07613327122947NA29-9100229-910022017-03-31
07613327122978NA29-9300229-930022017-12-01
07613327123326NA29-9200429-920042017-03-31
37613154881872PINABALL6003-003-0906003-003-0902016-09-21
57613252088436TLS, Quintube663066302016-08-24
07613327465532NA92-0023292-002322019-05-03
07613327465549NA92-0023092-002302019-05-03
04546540134790NA01-0323001-032302017-01-11
04546540134974NA01-0401001-040102016-12-08
04546540134998NA01-0407001-040702016-12-08
04546540135018NA01-0410001-041002016-12-08
04546540138477NA01-0956101-095612016-12-08
04546540141514NA01-1531501-153152017-01-11
04546540143242NA01-1971501-197152016-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806390889049Leforte Neuro System Bone PlateJeil Medical CorporationHBW2023-11-30
07613327543032DELTAStryker Leibinger GmbH & Co. KGHBW2020-12-15
08809595972837Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-12-30
08809595972868Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-12-30
08809595972882Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-12-30
08809595972707Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-02-13
08809595972714Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-02-13
08809595972721Neuro Plating SystemOSTEONIC CO.,Ltd.HBW2019-02-13
07613327423648DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327423655DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327423662DELTAStryker Leibinger GmbH & Co. KGHBW2018-05-22
07613327177534DELTAStryker Leibinger GmbH & Co. KGHBW2018-04-16
08809265151982Leforte Neuro System Bone PlateJeil Medical CorporationHBW2018-04-12
08806390862271Leforte Neuro System Bone PlateJeil Medical CorporationHBW2018-02-26
08806390861953Leforte Neuro System Bone PlateJeil Medical CorporationHBW2018-01-22
08806390855150Sterile NS SystemJeil Medical CorporationHBW2017-10-13
08806390855174Sterile NS SystemJeil Medical CorporationHBW2017-10-13
08806390855198Sterile NS SystemJeil Medical CorporationHBW2017-10-13
08806390855211Sterile NS SystemJeil Medical CorporationHBW2017-10-13
08806390854641Sterile NS SystemJeil Medical CorporationHBW2017-09-20
07613327177510DELTAStryker Leibinger GmbH & Co. KGHBW2017-03-09
07613327177541DELTAStryker Leibinger GmbH & Co. KGHBW2017-03-09
10887587057255RapidSorbSynthes GmbHHBW2016-10-07
10887587057262RapidSorbSynthes GmbHHBW2016-10-07
10887587057279RapidSorbSynthes GmbHHBW2016-10-07
10887587061573RapidSorbSynthes GmbHHBW2016-10-07
10887587061580RapidSorbSynthes GmbHHBW2016-10-07
10887587061597RapidSorbSynthes GmbHHBW2016-10-07
10887587061603RapidSorbSynthes GmbHHBW2016-10-07
10887587066929RapidSorbSynthes GmbHHBW2016-10-07