FDA.reportPublic FDA data

MySpine Cervical Guide

Primary DI
07630542702778
Brand
MySpine Cervical Guide
Company
Medacta International SA
Model
7.1307S
Device description
MySpine Cervical right guide C07 long 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
07630542702778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630542702778076305427027787630542702778

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
07630542762482GMK Extension02.12.0110APFL2026-09-18
07630542762499GMK Extension02.12.0110APFR2026-09-18
07630542762505GMK Extension02.12.0111APFL2026-09-18
07630542762512GMK Extension02.12.0111APFR2026-09-18
07630542762529GMK Extension02.12.0112APFL2026-09-18
07630542762536GMK Extension02.12.0112APFR2026-09-18
07630542762543GMK Extension02.12.0113APFL2026-09-18
07630542762550GMK Extension02.12.0113APFR2026-09-18
07630542762567GMK Extension02.12.0114APFL2026-09-18
07630542762574GMK Extension02.12.0114APFR2026-09-18
07630542762581GMK Extension02.12.0117APFL2026-09-18
07630542762598GMK Extension02.12.0117APFR2026-09-18
07630542762604GMK Extension02.12.0120APFL2026-09-18
07630542762611GMK Extension02.12.0120APFR2026-09-18
07630542762628GMK Extension02.12.0210APFL2026-09-18
07630542762635GMK Extension02.12.0210APFR2026-09-18
07630542762642GMK Extension02.12.0211APFL2026-09-18
07630542762659GMK Extension02.12.0211APFR2026-09-18
07630542762666GMK Extension02.12.0212APFL2026-09-18
07630542762673GMK Extension02.12.0212APFR2026-09-18

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
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
07630542702846MySpine Cervical GuideMedacta International SAQSD2023-12-21