FDA.reportPublic FDA data

My Spine guides

Primary DI
07630040716833
Brand
My Spine guides
Company
Medacta International SA
Model
7.0552S
Device description
MySpine LP drill pilot guide L02 STERILE
Published
2026-01-22
Public version status
New
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
PQCPedicle screw placement guide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQCPedicle Screw Placement GuideOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173472000
K203673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173472000MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.2018-04-19PQC
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
07630040716833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630040716833076300407168337630040716833

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

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
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
07630971243712AMIStem-P Short Neck01.18.4672020-01-29
07630971243729AMIStem-P Short Neck01.18.4682020-01-29
07630971243736AMIStem-P Short Neck01.18.4692020-01-29
07630971243743AMIStem-P Short Neck01.18.4702020-01-29
07630971243750AMIStem-P Short Neck01.18.4712020-01-29
07630971243767AMIStem-P Short Neck01.18.4722020-01-29
07630971243774AMIStem-P Short Neck01.18.4732020-01-29
07630971243781AMIStem-P Short Neck01.18.4742020-01-29
07630971243798AMIStem-P Short Neck01.18.4752020-01-29
07630971243804AMIStem-P Short Neck01.18.4762020-01-29
07630971243811AMIStem-P Short Neck01.18.4772020-01-29
07630971243828AMIStem-P Short Neck01.18.4782020-01-29

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
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
07630040717502My Spine guidesMedacta International SAPQC2026-01-22