FDA.reportPublic FDA data

MySpine Cervical Guide

Primary DI
07630542703270
Brand
MySpine Cervical Guide
Company
Medacta International SA
Model
7.1352S
Device description
MySpine Cervical lateral mass guide C02 short STE
Published
2023-12-21
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
QSDPosterior Cervical Screw Placement Guide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSDPosterior Cervical Screw Placement GuideOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231515000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231515000MySpine Cervical GuidesMedacta International S.A.2023-12-07QSD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630542703270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630542703270076305427032707630542703270

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
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
07630040714198MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630040714204MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630040714211MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630040714228MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630040714235MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630040714242MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630040714259MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630040714266MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630040714273MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630040714280MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630040714297MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630040714303MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702662MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702679MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702686MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702693MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702709MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702716MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702723MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702730MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702747MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702754MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702761MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702778MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702785MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702792MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702808MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702815MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702822MySpine Cervical GuideMedacta International SAQSD2023-12-21
07630542702839MySpine Cervical GuideMedacta International SAQSD2023-12-21