FDA.reportPublic FDA data

ST.A.R. 90 F4

Primary DI
08032909629930
Brand
ST.A.R. 90 F4
Company
CITIEFFE SRL
Model
Bone screws guide
Catalog number
F4-0215
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDWPin, Fixation, Threaded
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113384000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113384000EXTERNAL FIXATOR ST.A R 90 F4Citieffe2012-05-01KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08032909629930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08032909629930080329096299308032909629930

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Dry and clean environment and avoid damaging the packing. Room temperature.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+39051721850info@citieffe.com

Regulatory Flags#

DUNS number
431406875
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
08059386748701Orthopaedic Surgical InstrumentsEntry reamer head ø8.5mm, hole ø2.7mm5112-0852026-05-27
08059386748718ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSHandle for scalpel ø7x200mm STERILE40462026-05-26
08059386748725ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSHandle for scalpel ø8x400mm STERILE40472026-05-26
08032909626380ST.A.R. 90 F4Pin and rod clamp kitF4-52202026-03-17
08059386742440Orthopaedic Manual Surgical InstrumentsSpanner 9-11mmSF10192026-03-17
08059386744369RONDO'Ruler for Rondo' screws ø3-4-5mmVP-920212026-03-17
08059386748244RONDO'Rondo' screws ø3-4-5mm instrument tray, emptyFN9101022026-03-17
08059386748251Orthopaedic Manual Surgical InstrumentsDiapason hammer gr.300382672026-03-17
08059386748237Orthopaedic Surgical InstrumentsWire tensionerSF6470P2026-03-16
08051739535730ST.A.R. 90 F4Knee fixator distractorF4-27462026-03-10
08059386748176ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSScrews ruler kit with drill bit, ø2.5x150mmDT0720342026-02-10
08059386748183ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSScrew ruler for drill bit L.150mmDT0720352026-02-10
08059386748190ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSNails ruler kit with wire ø2x600mmDT0720332026-02-10
08052990971299Orthopaedic Surgical InstrumentsQuick-connect adapter for screw ø4mmSF13042018-12-15
08052990971305Orthopaedic Surgical InstrumentsQuick-connect adapter for screw ø5mmSF13052018-12-15
08052990971312Orthopaedic Surgical InstrumentsQuick-connect adapter for screw ø6mmSF13062018-12-15
08059386742280Orthopaedic Surgical InstrumentsImpactor/extractor guideFN9000802025-11-05
08059386742518ESTREMO FIBULAR NAILEstremo Fibular Nail end cap, standardFN0000012025-12-15
08059386742525ESTREMO FIBULAR NAILEstremo Fibular Nail end cap, 2.5mmFN0000022025-12-15
08059386742532ESTREMO FIBULAR NAILEstremo Fibular Nail end cap, 5mmFN0000052025-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08032909626380ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-17
08032909624256ST.A.R. 90 F4CITIEFFE SRLJDW2024-09-11
08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624270ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624317ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624355ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624362ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909627639DOLPHIXCITIEFFE SRLKTT2020-01-10
08051739531237DOLPHIXCITIEFFE SRLJDW2019-05-18
08051739531244DOLPHIXCITIEFFE SRLKTT2019-05-18
08051739531251DOLPHIXCITIEFFE SRLJDW2019-05-18
08051739531268DOLPHIXCITIEFFE SRLJDW2018-10-17
08051739531268DOLPHIXCITIEFFE SRLKTT2018-10-17
08051739531275DOLPHIXCITIEFFE SRLKTT2018-10-17
08051739531275DOLPHIXCITIEFFE SRLJDW2018-10-17
08051739531282DOLPHIXCITIEFFE SRLKTT2018-10-17
08051739531282DOLPHIXCITIEFFE SRLJDW2018-10-17
08051739531299DOLPHIXCITIEFFE SRLKTT2018-10-17
08051739531299DOLPHIXCITIEFFE SRLJDW2018-10-17
08051739531305DOLPHIXCITIEFFE SRLKTT2018-10-17
08051739531305DOLPHIXCITIEFFE SRLJDW2018-10-17
08032909628438DOLPHIXCITIEFFE SRLKTT2018-09-28
08032909628438DOLPHIXCITIEFFE SRLJDW2018-09-28
07613327079241HOFFMANNStryker GmbHKTT2018-09-24
07613327079272HOFFMANNStryker GmbHKTT2018-09-24
07613327079333HOFFMANNStryker GmbHKTT2018-09-24
07613327079395HOFFMANNStryker GmbHKTT2018-09-24
07613327079401HOFFMANNStryker GmbHKTT2018-09-24
07613327079449HOFFMANNStryker GmbHKTT2018-09-24
07613327079470HOFFMANNStryker GmbHKTT2018-09-24