FDA.reportPublic FDA data

My Spine Low Profile Placement Guides

Primary DI
07630971257771
Brand
My Spine Low Profile Placement Guides
Company
Medacta International SA
Model
7.0426
Device description
MySpine LP vertebra L06
Published
2022-02-10
Public version status
Update
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
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
07630971257771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630971257771076309712577717630971257771

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
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
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
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00840311244928Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244935Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244942Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245017Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245024Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245062Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245079Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
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00840311245239Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245253Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245284Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245345Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245369Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311245970Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246007Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246014Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246045Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246113Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246175Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246250Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246267Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311246298Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03