FDA.reportPublic FDA data

DOLPHIX

Primary DI
08056711920320
Brand
DOLPHIX
Company
CITIEFFE SRL
Model
Dolphix cable ties (4 pcs)
Catalog number
DF900001
Published
2021-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
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
K163323000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163323000Dolphix® External Fixation System MR ConditionalCitieffe S.R.L.2017-03-20KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056711920320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056711920320080567119203208056711920320

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

Contacts#

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

Regulatory Flags#

DUNS number
431406875
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08059386749203Orthopaedic Surgical InstrumentsCephalic drill with notchesEBA-52722026-10-23
08056711926636Orthopaedic Manual Surgical InstrumentsWeitlaner retractor314312026-10-09
08059386748688Orthopaedic Surgical InstrumentsCountersink for Eba One screws ø5.2mm HudsonEBA-52822026-07-21
08059386748695ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSScrews depth gaugeDT0300642026-06-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327616859HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616880HOFFMANN LRFStryker GmbHKTT2026-07-23
18032568033229Surgical InstrumentsORTHOFIX SRLJDW2026-07-23
18032568033236Surgical InstrumentsORTHOFIX SRLJDW2026-07-23
18032568036008WRIST FIXATION SYSTEMSORTHOFIX SRLJDW2026-07-23
07613327616835HOFFMANN LRFStryker GmbHKTT2026-07-21
07613327616866HOFFMANN LRFStryker GmbHKTT2026-07-21
07613327618501HOFFMANN LRFStryker GmbHJDW2026-07-21
00889795154620Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154637Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154644Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154651Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
10888867544571Arthrex®ARTHREX, INC.KTT2026-03-13
10886982346872MAXFRAMESynthes GmbHKTT2025-01-29
00810028396166EF1Medshape, Inc.KTT2024-07-09
00810028396340EF1Medshape, Inc.KTT2024-07-09
00810028396333EF1Medshape, Inc.KTT2024-05-31
00810028396357EF1Medshape, Inc.KTT2024-05-31
00810028396371EF1Medshape, Inc.KTT2024-05-31
00810028396159EF1Medshape, Inc.KTT2024-05-31
00810028396173EF1Medshape, Inc.KTT2024-05-31
00810028396142EF1Medshape, Inc.KTT2024-05-31
00810028396364EF1Medshape, Inc.KTT2024-05-31
00810028396388EF1Medshape, Inc.KTT2024-05-31
10886982338778MAXFRAMESYNTHES (U.S.A.) LPKTT2024-02-05
10886982343710MAXFRAMESynthes GmbHKTT2024-01-04
10886982343727MAXFRAMESynthes GmbHKTT2024-01-04
10886982343734MAXFRAMESynthes GmbHKTT2024-01-04
10886982338570MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338587MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26