FDA.reportPublic FDA data

M.U.S.T. Pedicle Screw System

Primary DI
07630971280861
Brand
M.U.S.T. Pedicle Screw System
Company
Medacta International SA
Model
03.79.049
Device description
MUST LT 15mm LONG - Pedicle Screw Ø8x80 Fen
Published
2024-07-12
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
PMLBone Cement, Posterior Screw Augmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMLBone Cement, Posterior Screw AugmentationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241034000Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.2024-06-12PML

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630971280861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630971280861076309712808617630971280861

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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
07630040795166Surgical Manual Instrument02.12.10.08452026-09-25
07630542792359Surgical Manual Instrument02.12.10.31272026-09-25
07630040738767Surgical Manual Instrument01.22.10.00512026-09-21
07630345706584M-Vizion Femoral Revision System Extension01.22.10.07812026-09-21
07630345706591M-Vizion Femoral Revision System Extension01.22.10.07822026-09-21
07630345706607M-Vizion Femoral Revision System Extension01.22.10.07832026-09-21
07630345706614M-Vizion Femoral Revision System Extension01.22.10.07842026-09-21
07630345706621M-Vizion Femoral Revision System Extension01.22.10.07852026-09-21
07630345706638M-Vizion Femoral Revision System Extension01.22.10.07862026-09-21
07630345706645M-Vizion Femoral Revision System Extension01.22.10.07872026-09-21
07630345706652M-Vizion Femoral Revision System Extension01.22.10.07882026-09-21
07630345706669M-Vizion Femoral Revision System Extension01.22.10.07892026-09-21
07630345706676M-Vizion Femoral Revision System Extension01.22.10.07902026-09-21
07630345706683M-Vizion Femoral Revision System Extension01.22.10.07912026-09-21
07630345706690M-Vizion Femoral Revision System Extension01.22.10.07922026-09-21
07630345706706M-Vizion Femoral Revision System Extension01.22.10.07932026-09-21
07630345706713M-Vizion Femoral Revision System Extension01.22.10.07942026-09-21
07630345706720M-Vizion Femoral Revision System Extension01.22.10.07952026-09-21
07630542702112Surgical Manual Instrument01.22.10.01742026-09-21
07630542723162M-Vizion Femoral Revision System Extension01.22.10.04022026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290117353738CarboClear Hybrid Pedicle Screw SystemCARBOFIX ORTHOPEDICS LTDPML2026-07-27
07640172554227VADER Pedicle System, Nut Screw, Tiicotec AGPML2026-04-30
07640172554234VADER Pedicle System, Cross-Link, Ti, 30/34 mmicotec AGPML2026-04-30
07640172554241VADER Pedicle System, Cross-Link, Ti, 33/42 mmicotec AGPML2026-04-30
07640172554258VADER Pedicle System, Cross-Link, Ti, 40/53 mmicotec AGPML2026-04-30
07640172554265VADER Pedicle System, Cross-Link, Ti, 50/70 mmicotec AGPML2026-04-30
07640172553909icotec Systems, Saw bladeicotec AGPML2025-09-01
07640172553848"icotec Systems, Handle, 1/4"" Coupling"icotec AGPML2025-08-13
07640172553855icotec Systems, Fixation deviceicotec AGPML2025-08-13
07640172553862icotec Systems, Deburring toolicotec AGPML2025-08-13
07640172553879icotec Systems, Handle for deburrer, M6icotec AGPML2025-08-13
07640172552537VADER Pedicle System, Trephine for Ø 4.5 mm Screw, Ø 4.5 mmicotec AGPML2025-06-02
07640172552858VADER Pedicle System, Axial Connector, Ø 6.0 mm - Ø 6.0 mmicotec AGPML2025-03-05
07640172552865VADER Pedicle System, Parallel Connector, Closed, Ø 6.0 mm - Ø 6.0 mmicotec AGPML2025-03-05
07640172552872icotec Systems, Torque-Limiting Adapter, 3.5 Nmicotec AGPML2025-03-05
07640172552889VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nmicotec AGPML2025-03-05
07640172553572VADER Pedicle System, Torque Wrench for Connectors, T15, 3.5 Nmicotec AGPML2025-03-05
07290117352113CarboClear Hybrid Pedicle Screw SystemCARBOFIX ORTHOPEDICS LTDPML2024-07-15
07640172552742VADER Pedicle System, VADER Pedicle System Rod-2-size, Container, completeicotec AGPML2023-09-08
07640305165481PERLA® TL MISSpineArt SAPML2023-06-27
07640305165504PERLA® TL MISSpineArt SAPML2023-06-27
07640305165511PERLA® TL MISSpineArt SAPML2023-06-27
07640172551950VADER Pedicle System, Saw bladeicotec AGPML2023-01-13
07640172552285VADER Pedicle System, Trephine for Ø 5.5 mm Screw, Ø 5.5 mmicotec AGPML2023-01-13
07640172552292VADER Pedicle System, Trephine for Ø 6.5 mm Screw, Ø 6.5 mmicotec AGPML2023-01-13
07640172552308VADER Pedicle System, Trephine for Ø 7.5 mm Screw, Ø 7.5 mmicotec AGPML2023-01-13
07640172551967"VADER Pedicle System, Handle, 1/4"" Coupling"icotec AGPML2023-01-13
07640172551981VADER Pedicle System, Deburring toolicotec AGPML2023-01-13
07640172551998VADER Pedicle System, Trial rod, flexible, Ø 5.5 mm; L = 300 mmicotec AGPML2023-01-13
07640172552001VADER Pedicle System, Template for HT S-rodsicotec AGPML2023-01-13