FDA.reportPublic FDA data

StealthFix Intraosseous Fixation System

Primary DI
00810082898620
Brand
StealthFix Intraosseous Fixation System
Company
Medartis Inc.
Model
SF2407
Device description
StealthFix STD 20 Guide LowPro
Published
2023-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232324000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232324000StealthFix Intraosseous Fixation SystemMedartis, Inc.2023-08-30JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810082898620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810082898620008100828986208100828986200810082898620

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
192756786
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810082892901Stratum AnkleSAPTTCSMLT2023-06-01
00810082891409Stratum AnkleSANLS3542S2023-05-31
00810082891454Stratum AnkleSANLS3552S2023-05-31
00810082891485Stratum AnkleSANLS3558S2023-05-31
00810082891508Stratum AnkleSANLS3562S2023-05-31
00810082891546Stratum AnkleSANLS3570S2023-05-31
00810082891584Stratum AnkleSANLS3516NS2023-05-31
00810082890341Stratum AnkleSALS3516NS2023-05-26
00810082890433Stratum AnkleSALS3534NS2023-05-26
00810082890778Stratum AnkleSALS5040S2023-05-26
00810082890846Stratum AnkleSALS5054S2023-05-26
00810082890921Stratum AnkleSALS5070S2023-05-26
00810082891010Stratum AnkleSALS5026NS2023-05-26
00810082891034Stratum AnkleSALS5030NS2023-05-26
00810082896817Stratum AnkleSANLS3580NS2023-05-26
00810082896848Stratum AnkleSANLS5076S2023-05-26
00810082896855Stratum AnkleSANLS5078S2023-05-26
00817701027553Stratum RSSTRM-NL-2412RS-ST2020-11-10
00817701027690Stratum RSSTRM-NL-2440RS-ST2020-11-10
00817701020059Nextra Hammertoe Correction SystemNX-3532K-SC2016-09-26

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Primary DI, Brand, Company table
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G4533312BT0PEAK MEDICALPeak Medical Distribution Inc.LXH2026-06-03
07613327648355PANGEAStryker GmbHLXH2026-06-02
07613327648379PANGEAStryker GmbHLXH2026-06-02
00199150077359Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00199150077366Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00816127027215InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027246InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027253InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00843511128777Omnia Medical TiBrid™-A/SAOMNIA MEDICAL, LLCLXH2026-06-01
00857915007712ObturatorA.M. SURGICAL, INC.LXH2026-06-01
00857915007729CannulaA.M. SURGICAL, INC.LXH2026-06-01
00857915007736RaspA.M. SURGICAL, INC.LXH2026-06-01
07899258648729Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-06-01
B756007053002000Torque Wrench Adaptor HEX 3.5mmShukla MedicalLXH2026-06-01
10884450587727PowerCURVE®Merit Medical Systems, Inc.LXH2026-05-30
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