FDA.reportPublic FDA data

MySpine Unilateral Guide

Primary DI
07630345787101
Brand
MySpine Unilateral Guide
Company
Medacta International SA
Model
7.1064
Device description
MySpine MC Unilateral left guide L04
Published
2023-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PQCPedicle Screw Placement Guide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQCPedicle Screw Placement GuideOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231483000MySpine Unilateral GuidesMedacta International S.A.2023-07-21PQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630345787101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630345787101076303457871017630345787101

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, single-useA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
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
07630040716574My Spine guidesMedacta International SAPQC2026-01-22
07630040716598My Spine guidesMedacta International SAPQC2026-01-22
07630040716611My Spine guidesMedacta International SAPQC2026-01-22
07630040716635My Spine guidesMedacta International SAPQC2026-01-22
07630040716659My Spine guidesMedacta International SAPQC2026-01-22
07630040716673My Spine guidesMedacta International SAPQC2026-01-22
07630040716697My Spine guidesMedacta International SAPQC2026-01-22
07630040716710My Spine guidesMedacta International SAPQC2026-01-22
07630040716734My Spine guidesMedacta International SAPQC2026-01-22
07630040716758My Spine guidesMedacta International SAPQC2026-01-22
07630040716772My Spine guidesMedacta International SAPQC2026-01-22
07630040716796My Spine guidesMedacta International SAPQC2026-01-22
07630040716819My Spine guidesMedacta International SAPQC2026-01-22
07630040716833My Spine guidesMedacta International SAPQC2026-01-22
07630040716857My Spine guidesMedacta International SAPQC2026-01-22
07630040716871My Spine guidesMedacta International SAPQC2026-01-22
07630040716895My Spine guidesMedacta International SAPQC2026-01-22
07630040717243My Spine guidesMedacta International SAPQC2026-01-22
07630040717267My Spine guidesMedacta International SAPQC2026-01-22
07630040717281My Spine guidesMedacta International SAPQC2026-01-22
07630040717304My Spine guidesMedacta International SAPQC2026-01-22
07630040717328My Spine guidesMedacta International SAPQC2026-01-22
07630040717342My Spine guidesMedacta International SAPQC2026-01-22
07630040717366My Spine guidesMedacta International SAPQC2026-01-22
07630040717380My Spine guidesMedacta International SAPQC2026-01-22
07630040717403My Spine guidesMedacta International SAPQC2026-01-22
07630040717427My Spine guidesMedacta International SAPQC2026-01-22
07630040717441My Spine guidesMedacta International SAPQC2026-01-22
07630040717465My Spine guidesMedacta International SAPQC2026-01-22
07630040717489My Spine guidesMedacta International SAPQC2026-01-22