FDA.reportPublic FDA data

MATTA

Primary DI
04546540873552
Brand
MATTA
Company
Stryker GmbH
Model
390086
Catalog number
390086
Device description
Reduction Pin
Published
2015-09-24
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
KTWAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001614000STRYKER TRAUMA PELVIC SETHowmedica Osteonics Corp.2000-08-04KTW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540873552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540873552045465408735524546540873552

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length150Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327605716PANGEA5422525422522026-06-02
07613327648331PANGEA5421605421602026-06-02
07613327648355PANGEA7039197039192026-06-02
07613327648362PANGEA5421615421612026-06-02
07613327648379PANGEA7039187039182026-06-02
37613153159729PROFYLE59-1204959-120492015-09-24
37613153159736PROFYLE59-1704959-170492015-06-24
37613153159743PROFYLE59-2304959-230492015-07-03
07613154583829PROFYLE59-12049E59-12049E2015-06-24
07613154583836PROFYLE59-17049E59-17049E2015-06-24
07613154583843PROFYLE59-23049E59-23049E2015-07-03
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982218735NASYNTHES (U.S.A.) LPKTW2018-07-18
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08809265150237Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150244Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150251Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150268Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150275Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150282Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150299Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150305Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150312Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150329Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
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08809265150510Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150527Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150534Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150541Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150572Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150589Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150596Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150602Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150671Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265150688Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265151203Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265151210Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
08809265151227Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24
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08809265151241Leforte System Bone PlateJeil Medical CorporationKTW2015-09-24