FDA.reportPublic FDA data

MySpine Cervical Guide

Primary DI
07630040714273
Brand
MySpine Cervical Guide
Company
Medacta International SA
Model
7.0606
Device description
MySpine Cervical vertebra C06
Published
2023-12-21
Public version status
New
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
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
07630040714273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630040714273076300407142737630040714273

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
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
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
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
07630542702846MySpine Cervical GuideMedacta International SAQSD2023-12-21