FDA.reportPublic FDA data

M.U.S.T. Hooks

Primary DI
07630030836213
Brand
M.U.S.T. Hooks
Company
Medacta International SA
Model
03.50.643
Device description
Offset Hook Left + Nut (1x) - Sterile
Published
2014-09-17
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
KWQAppliance, Fixation, Spinal Intervertebral Body
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141044000M.U.S.T. EXTENSIONMedacta International2014-08-18NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630030836213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630030836213076300308362137630030836213

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation systemAn assembly of 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. 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
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
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
00840606186544OMEGA XPSPINAL ELEMENTS, INC.KWP2026-09-22
00840606186551OMEGA XPSPINAL ELEMENTS, INC.KWP2026-09-22
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598164Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24