FDA.reportPublic FDA data

Mecta-C Cervical Plate System

Primary DI
07630030842283
Brand
Mecta-C Cervical Plate System
Company
Medacta International SA
Model
03.71.146
Device description
Unsterile fixed self-drilling screw diam. 4x18mm
Published
2014-11-18
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
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
07630030842283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630030842283076300308422837630030842283

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
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
00810017913664Saber-C Body (PT), 12x15x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.KWQ2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.KWQ2026-06-05
00840283407949VyPlate™VY SPINE LLCKWQ2026-06-05
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
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00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
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00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422664RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422671RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422688RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422695RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422701RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422718RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422770RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422787RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422794RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05