FDA.reportPublic FDA data

Mecta-C Cervical Plate System

Primary DI
07630030841491
Brand
Mecta-C Cervical Plate System
Company
Medacta International SA
Model
03.70.294
Device description
Fixed self-tapping screw diam. 4x20mm (4x)
Published
2015-10-18
Public version status
Update
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140361000META-C CERVICAL PLATEMedacta International2014-06-12KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630030841491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630030841491076300308414917630030841491

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, sterile, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold plates, or other stabilization device, to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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
07630542720680Surgical Manual Instrument03.22.10.10572026-10-14
07630542720895Surgical Manual Instrument03.22.10.11122026-10-14
07630542721045Surgical Manual Instrument03.22.10.11142026-10-14
07630542721052Surgical Manual Instrument03.22.10.11172026-10-14
07630542721069Surgical Manual Instrument03.22.10.11182026-10-14
07630542721304Surgical Manual Instrument03.22.10.12422026-10-14
07630542721311Surgical Manual Instrument03.22.10.12432026-10-14
07630542721335Surgical Manual Instrument03.22.10.13422026-10-14
07630699705950Shoulder System04.01.10.12142026-10-01
07630699705967Shoulder System04.01.10.12152026-10-01
07630699705974Shoulder System04.01.10.12162026-10-01
07630699705998Shoulder System04.01.10.12182026-10-01
07630699706001Shoulder System04.01.10.12192026-10-01
07630699706018Shoulder System04.01.10.12202026-10-01
07630699706032Shoulder System04.01.10.12222026-10-01
07630699706049Shoulder System04.01.10.12232026-10-01
07630699706056Shoulder System04.01.10.12242026-10-01
07630345775320Shoulder System04.01.10.06972026-09-28
07630345775375Shoulder System04.01.10.07022026-09-28
07630542727528Shoulder System04.01.10.08812026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-15
10889981217204MeridianSeaspine Orthopedics CorporationKWQ2022-08-25
10889981230838RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230845RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230852RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230869RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230876RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230883RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981230890RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231040RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231057RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231064RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231071RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981231088RegattaSeaspine Orthopedics CorporationKWQ2021-02-02
10889981214289MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214296MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214302MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214319MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214326MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214333MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214340MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214357MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214364MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214371MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214388MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214494MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214500MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214517MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214524MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214531MeridianSeaspine Orthopedics CorporationKWQ2020-12-30