FDA.reportPublic FDA data

M.U.S.T. Sacral Iliac Screw System

Primary DI
07630030879920
Brand
M.U.S.T. Sacral Iliac Screw System
Company
Medacta International SA
Model
03.65.108
Device description
MUST-PT Ti Screw 8x110mm, Thread 35mm, Sterile
Published
2026-01-20
Public version status
New
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
OURSacroiliac joint fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171595000M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.2017-08-02OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630030879920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630030879920076300308799207630030879920

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implant, coatedAn implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of metal [e.g., titanium (Ti)] with a porous plasma spray coating, and typically in the form of a cylinder or rod, possibly with a triangular cross-section. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630971243637AMIStem-P Short Neck01.18.4592020-01-29
07630971243644AMIStem-P Short Neck01.18.4602020-01-29
07630971243651AMIStem-P Short Neck01.18.4612020-01-29
07630971243668AMIStem-P Short Neck01.18.4622020-01-29
07630971243675AMIStem-P Short Neck01.18.4632020-01-29
07630971243682AMIStem-P Short Neck01.18.4642020-01-29
07630971243699AMIStem-P Short Neck01.18.4652020-01-29
07630971243705AMIStem-P Short Neck01.18.4662020-01-29
07630971243712AMIStem-P Short Neck01.18.4672020-01-29
07630971243729AMIStem-P Short Neck01.18.4682020-01-29
07630971243736AMIStem-P Short Neck01.18.4692020-01-29
07630971243743AMIStem-P Short Neck01.18.4702020-01-29
07630971243750AMIStem-P Short Neck01.18.4712020-01-29
07630971243767AMIStem-P Short Neck01.18.4722020-01-29
07630971243774AMIStem-P Short Neck01.18.4732020-01-29
07630971243781AMIStem-P Short Neck01.18.4742020-01-29
07630971243798AMIStem-P Short Neck01.18.4752020-01-29
07630971243804AMIStem-P Short Neck01.18.4762020-01-29
07630971243811AMIStem-P Short Neck01.18.4772020-01-29
07630971243828AMIStem-P Short Neck01.18.4782020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327075830ASNISStryker GmbHOUR2015-11-11
07613327076189ASNISStryker GmbHOUR2015-11-11
07613327076301ASNISStryker GmbHOUR2015-11-11
07613327076554ASNISStryker GmbHOUR2015-11-11
07613327076721ASNISStryker GmbHOUR2015-11-11
07613327076929ASNISStryker GmbHOUR2015-11-11
07613327077049ASNISStryker GmbHOUR2015-11-11
07613327077308ASNISStryker GmbHOUR2015-11-11
07613327077315ASNISStryker GmbHOUR2015-11-11
07613327077346ASNISStryker GmbHOUR2015-11-11
07613327077391ASNISStryker GmbHOUR2015-11-11
07613327077414ASNISStryker GmbHOUR2015-11-11
07613327077483ASNISStryker GmbHOUR2015-11-11
07613327077513ASNISStryker GmbHOUR2015-11-11
07613327077544ASNISStryker GmbHOUR2015-11-11
07613327077582ASNISStryker GmbHOUR2015-11-11
07613327077605ASNISStryker GmbHOUR2015-11-11
07613327077612ASNISStryker GmbHOUR2015-11-11
07613327077643ASNISStryker GmbHOUR2015-11-11
07613327077674ASNISStryker GmbHOUR2015-11-11
07613327077704ASNISStryker GmbHOUR2015-11-11
07613327077735ASNISStryker GmbHOUR2015-11-11
07613154158980NAStryker GmbHOUR2015-09-24
07613252232674ASNISStryker GmbHOUR2015-09-24
07613252232681ASNISStryker GmbHOUR2015-09-24
07613252232698ASNISStryker GmbHOUR2015-09-24
07613252232704ASNISStryker GmbHOUR2015-09-24
07613252232711ASNISStryker GmbHOUR2015-09-24
07613252232728ASNISStryker GmbHOUR2015-09-24
07613252232735ASNISStryker GmbHOUR2015-09-24