FDA.reportPublic FDA data

MySpine Unilateral Guide

Primary DI
07630345786425
Brand
MySpine Unilateral Guide
Company
Medacta International SA
Model
7.1012
Device description
MySpine Unilateral left guide T12
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
07630345786425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630345786425076303457864257630345786425

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
07630699705950Shoulder System04.01.10.12142026-10-01
07630699705967Shoulder System04.01.10.12152026-10-01
07630699705974Shoulder System04.01.10.12162026-10-01
07630699705998Shoulder System04.01.10.12182026-10-01
07630699706001Shoulder System04.01.10.12192026-10-01
07630699706018Shoulder System04.01.10.12202026-10-01
07630699706032Shoulder System04.01.10.12222026-10-01
07630699706049Shoulder System04.01.10.12232026-10-01
07630699706056Shoulder System04.01.10.12242026-10-01
07630345775320Shoulder System04.01.10.06972026-09-28
07630345775375Shoulder System04.01.10.07022026-09-28
07630542727528Shoulder System04.01.10.08812026-09-28
07630542727535Shoulder System04.01.10.08822026-09-28
07630542727542Shoulder System04.01.10.08832026-09-28
07630542727559Shoulder System04.01.10.08842026-09-28
07630542794964Surgical Manual Instrument04.01.10.10132026-09-28
07630542794971Surgical Manual Instrument04.01.10.10142026-09-28
07630542794988Surgical Manual Instrument04.01.10.10152026-09-28
07630542794995Surgical Manual Instrument04.01.10.10162026-09-28
07630542795008Shoulder System04.01.10.10172026-09-28

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