FDA.reportPublic FDA data

My Spine Low Profile Placement Guides

Primary DI
07630030877957
Brand
My Spine Low Profile Placement Guides
Company
Medacta International SA
Model
7.0510S
Device description
MySpine LP guide T10 STERILE
Published
2016-09-01
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
MNIOrthosis, Spinal Pedicle Fixation
PQCPedicle screw placement guide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
PQCPedicle Screw Placement GuideOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153273000
K203673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153273000MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.2016-06-29MNI
K203673000MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)Medacta International S.A.2021-04-06PQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630030877957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630030877957076300308779577630030877957

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation 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. It may be used for the following applications: 1) to hold/align/fix bone preparation 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 between prosthesis components. This is a single-use device.

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
07630699705240Surgical Manual Instrument03.22.10.11652026-10-21
07630699705257Surgical Manual Instrument03.22.10.11662026-10-21
07630699705264Surgical Manual Instrument03.22.10.12672026-10-21
07630699705271Surgical Manual Instrument03.22.10.12682026-10-21
07630542720680Surgical Manual Instrument03.22.10.10572026-10-14
07630542720895Surgical Manual Instrument03.22.10.11122026-10-14
07630542721045Surgical Manual Instrument03.22.10.11142026-10-14
07630542721052Surgical Manual Instrument03.22.10.11172026-10-14
07630542721069Surgical Manual Instrument03.22.10.11182026-10-14
07630542721304Surgical Manual Instrument03.22.10.12422026-10-14
07630542721311Surgical Manual Instrument03.22.10.12432026-10-14
07630542721335Surgical Manual Instrument03.22.10.13422026-10-14
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

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Primary DI, Brand, Company table
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04047844130964DIPLOMATSIGNUS Medizintechnik GmbHMNI2026-10-26
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07290115935929Tube for K-wire over a k-wire technique 470mm (Nitinol)PREMIA SPINE LTDMNI2026-10-20
07290115935936Tube for XL K-Wire 450mmPREMIA SPINE LTDMNI2026-10-20
07290115935943Tube for K-Wires of 470mmPREMIA SPINE LTDMNI2026-10-20
07290115935950Tube for K-Wires up to 340mmPREMIA SPINE LTDMNI2026-10-20
07290115932874Cannulated Screwdriver inner shaftPREMIA SPINE LTDMNI2026-10-18
07290115932881Cannulated Screwdriver Handle AssyPREMIA SPINE LTDMNI2026-10-18
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10888857001459DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
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