FDA.reportPublic FDA data

M.U.S.T. Pedicle Screw System

Primary DI
07630542784705
Brand
M.U.S.T. Pedicle Screw System
Company
Medacta International SA
Model
03.68.1029
Device description
Pre-Contoured J-rod Ø5.5 CoCr -V
Published
2026-05-04
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
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253940000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253940000M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.2026-04-28NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630542784705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630542784705076305427847057630542784705

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

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
07630030883576Mpact 3D Metal Foam25070.2236HC2026-09-04
07630030883583Mpact 3D Metal Foam25070.2238HC2026-09-04
07630030883590Mpact 3D Metal Foam25070.2240HC2026-09-04
07630030883606Mpact 3D Metal Foam25070.2242HC2026-09-04
07630030883613Mpact 3D Metal Foam25070.2244HC2026-09-04
07630030883620Mpact 3D Metal Foam25070.2246HC2026-09-04
07630030883637Mpact 3D Metal Foam25070.2248HC2026-09-04
07630030883644Mpact 3D Metal Foam25070.2250HC2026-09-04
07630030883651Mpact 3D Metal Foam25070.2252HC2026-09-04
07630030883668Mpact 3D Metal Foam25070.2254HC2026-09-04
07630030883675Mpact 3D Metal Foam25070.2256HC2026-09-04
07630030883682Mpact 3D Metal Foam25070.2258HC2026-09-04
07630030883699Mpact 3D Metal Foam25070.2840HC2026-09-04
07630030883705Mpact 3D Metal Foam25070.2842HC2026-09-04
07630030883712Mpact 3D Metal Foam25070.2844HC2026-09-04
07630030883729Mpact 3D Metal Foam25070.2846HC2026-09-04
07630030883736Mpact 3D Metal Foam25070.2848HC2026-09-04
07630030883743Mpact 3D Metal Foam25070.2850HC2026-09-04
07630030883750Mpact 3D Metal Foam25070.2852HC2026-09-04
07630030883767Mpact 3D Metal Foam25070.2854HC2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157113384ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113391ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113407ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113414ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113421ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113438ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113445ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113452ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113469ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113476ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113483ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113490ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113506ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113513ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113520ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113537ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113544ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113551ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113568ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113575ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113582ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113599ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113605ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113612ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113629ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113636ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113643ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113650ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113667ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113674ZAVATION SCREWZavation LLCNKB2026-09-04