FDA.reportPublic FDA data

StealthFix Intraosseous Fixation System

Primary DI
00810082898644
Brand
StealthFix Intraosseous Fixation System
Company
Medartis Inc.
Model
SF3416
Device description
StealthFix STD Implant Tamp
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
JDRStaple, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

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
00810082898644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810082898644008100828986448100828986440810082898644

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustableA non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.

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
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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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