FDA.reportPublic FDA data

M.U.S.T. MINI Posterior Cervical Screws

Primary DI
07630971258785
Brand
M.U.S.T. MINI Posterior Cervical Screws
Company
Medacta International SA
Model
03.75.477
Device description
MUST MINI Polyaxial Screw 3.5 x 38 partial thread + nut
Published
2020-06-15
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
NKGPosterior Cervical Screw System

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200130000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200130000M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.2020-02-10NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630971258785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630971258785076309712587857630971258785

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

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
07630345700551NextAR TSA Platform5.3KSWNXAR2026-07-10
07630542776755Surgical Manual Instrument01.10.10.20922026-07-07
07630542778285Surgical Manual Instrument01.10.10.20932026-07-07
07630542778292Surgical Manual Instrument01.10.10.20942026-07-07
07630542791659Surgical Manual Instrument03.51.10.07412026-07-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000992316INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992323INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992330INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992347INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992453INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00840606192057Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192064Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192071Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192088Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192095Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192101Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192118Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192125Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192132Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192149Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192156Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192163Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192170Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192187Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192194Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192200Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192217Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192224Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192231Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192248Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192255Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192262Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192279Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192286Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192293Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24