FDA.reportPublic FDA data

M.U.S.T. MINI Anodized Rod

Primary DI
07630971299412
Brand
M.U.S.T. MINI Anodized Rod
Company
Medacta International SA
Model
03.75.650
Device description
MUST MINI Pre-curved anod Rod Ti 3.5x30mm (ste)
Published
2020-11-19
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
KWPAppliance, Fixation, Spinal Interlaminal
NKGOrthosis, Cervical Pedicle Screw Spinal Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203149000M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.2020-11-16NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630971299412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630971299412076309712994127630971299412

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.

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
07630542788314AMIStem-P13.000092026-06-08
07630542788321AMIStem-P13.000102026-06-08
07630542788338AMIStem-P13.000112026-06-08
07630542788345AMIStem-P13.000122026-06-08
07630542788352AMIStem-P13.000132026-06-08
07630542788369AMIStem-P13.000142026-06-08
07630542788376AMIStem-P13.000152026-06-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536163403neon3Ulrich GmbH & Co. KGNKG2026-06-09
04052536163403neon3Ulrich GmbH & Co. KGKWP2026-06-09
04052536163410neon3Ulrich GmbH & Co. KGNKG2026-06-09
04052536163410neon3Ulrich GmbH & Co. KGKWP2026-06-09
04052536162109neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162109neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162123neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162123neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162185neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162185neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162192neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162192neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162208neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162208neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194285neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194285neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536194292neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536194292neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194308neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536194308neon3Ulrich GmbH & Co. KGNKG2026-06-08
00197157082031ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082048ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082055ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082062ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082079ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082086ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082093ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082109ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082116ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082123ZAVATION SCREWZavation LLCKWP2026-06-05