FDA.reportPublic FDA data

NA

Primary DI
04546540195890
Brand
NA
Company
Stryker GmbH
Model
1806-0080S
Catalog number
1806-0080S
Device description
Guide Wire, Ball-Tipped, sterile
Published
2016-09-24
Public version status
Update
Distribution status
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
FZXGuide, Surgical, Instrument
MAYProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123604000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123604000ABG III MONOLITHIC HIP STEMHowmedica Osteonics Corp.2013-08-16MAY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540195890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540195890045465401958904546540195890

GMDN Terms#

Term, Definition table
TermDefinition
Bone nail guidewire, reusableA long, thin, metal rod designed to guide intramedullary canal devices for performing the implantation of an intramedullary nail to treat damaged bone. The rod is usually manually inserted into the canal to typically guide a surgical instrument (e.g., a reamer) and the implantable nail. This device is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). It may be used in femoral, tibial, humeral or supracondylar intramedullary canals. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length800Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481999654
Device count
1
Premarket exempt
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008100978037493.0mm GUIDE WIRE 355mmOsteocentric Technologies, Inc.FZX2026-06-02
00889024707382Persona Tensor Sizer Arm – LongZimmer, Inc.FZX2026-05-29
00889024707399Persona Tensor Sizer Arm – StdZimmer, Inc.FZX2026-05-29
00889024707405Persona Tensor Sizer BodyZimmer, Inc.FZX2026-05-29
008101182101673.7mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101744.2mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
008101182101815.5mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
10855068008577Steerable Guide Sleeve, Small ImplantCURVAFIX, INC.FZX2022-12-05
10855068008447Soft Tissue SleeveCURVAFIX, INC.FZX2022-06-20
10855068008454Drill SleeveCURVAFIX, INC.FZX2022-06-20
10855068008461Spiked Start Sleeve, CannulatedCURVAFIX, INC.FZX2022-06-20
10855068008478Steerable Guide SleeveCURVAFIX, INC.FZX2022-06-20
10886982066763NASYNTHES (U.S.A.) LPFZX2016-12-31
07613153071273RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071280RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071297RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071327RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071341RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071358RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071389RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071396RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071402RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071419RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071426RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071433RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071440RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071518RestorationHowmedica Osteonics Corp.MAY2015-09-24