FDA.reportPublic FDA data

NA

Primary DI
04546540391735
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
6007-425-000
Catalog number
6007-425-000
Device description
ANCHORING PIN 25MM/4MM
Published
2017-12-12
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
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540391735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540391735045465403917354546540391735

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
Length25Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316153956
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
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

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Primary DI, Brand, Company table
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00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
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