FDA.reportPublic FDA data

M.U.S.T. Midline Cortical (MC) Screw System

Primary DI
07630971293250
Brand
M.U.S.T. Midline Cortical (MC) Screw System
Company
Medacta International SA
Model
03.58.213
Device description
MUST MC Screw Ø4.5x35 cannulated
Published
2021-04-26
Public version status
Update
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210427000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210427000M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.2021-04-20NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630971293250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630971293250076309712932507630971293250

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

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
07630542720680Surgical Manual Instrument03.22.10.10572026-10-14
07630542720895Surgical Manual Instrument03.22.10.11122026-10-14
07630542721045Surgical Manual Instrument03.22.10.11142026-10-14
07630542721052Surgical Manual Instrument03.22.10.11172026-10-14
07630542721069Surgical Manual Instrument03.22.10.11182026-10-14
07630542721304Surgical Manual Instrument03.22.10.12422026-10-14
07630542721311Surgical Manual Instrument03.22.10.12432026-10-14
07630542721335Surgical Manual Instrument03.22.10.13422026-10-14
07630699705950Shoulder System04.01.10.12142026-10-01
07630699705967Shoulder System04.01.10.12152026-10-01
07630699705974Shoulder System04.01.10.12162026-10-01
07630699705998Shoulder System04.01.10.12182026-10-01
07630699706001Shoulder System04.01.10.12192026-10-01
07630699706018Shoulder System04.01.10.12202026-10-01
07630699706032Shoulder System04.01.10.12222026-10-01
07630699706049Shoulder System04.01.10.12232026-10-01
07630699706056Shoulder System04.01.10.12242026-10-01
07630345775320Shoulder System04.01.10.06972026-09-28
07630345775375Shoulder System04.01.10.07022026-09-28
07630542727528Shoulder System04.01.10.08812026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197157121051ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121068ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121075ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121082ZAVATION SCREWZavation LLCNKB2026-10-15
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00197157121129ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121136ZAVATION SCREWZavation LLCNKB2026-10-15
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00197157121174ZAVATION SCREWZavation LLCNKB2026-10-15
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00197157121204ZAVATION SCREWZavation LLCNKB2026-10-15
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