FDA.reportPublic FDA data

MAGEC

Primary DI
00887517834010
Brand
MAGEC
Company
Nuvasive, Inc.
Model
MC2-5070R
Device description
MAGEC 2 Rod, 5.0mm 70mm Offset
Published
2017-09-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
PGNGrowing rod system- magnetic actuation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGNGrowing Rod System- Magnetic ActuationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171791000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171791000MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated2017-08-31PGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517834010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517834010008875178340108875178340100887517834010

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)909-1800RA_UDI@nuvasive.com
+1800-475-9131nuvainfo@globusmedical.com

Regulatory Flags#

DUNS number
053950783
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517377692CoRoent68510122015-10-24
00887517390516CoRoent69102452015-10-24
00195377006424CoRoent6791713P26791713P22026-05-08
00195377006431CoRoent6791712P26791712P22026-05-08
00887517051905CoRoent6791715P26791715P22026-05-08
00887517051912CoRoent6791716P26791716P22026-05-08
00887517051929CoRoent6791812P26791812P22026-05-08
00887517051936CoRoent6791813P26791813P22026-05-08
00887517051943CoRoent6791814P26791814P22026-05-08
00887517051950CoRoent6791815P26791815P22026-05-08
00887517051967CoRoent6791816P26791816P22026-05-08
00887517180513MaXcess32000282022-07-20
00887517063434MaXcess10109872019-11-21
00887517074973MaXcess10254612019-11-21
00887517183323MaXcess32001202019-11-21
00887517183378MaXcess32002202019-11-21
00887517206084MaXcess34000332019-11-21
00887517206572MaXcess34000442019-11-21
00887517497222MaXcess32410022019-11-21
00887517729071MaXcess35000172019-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887517834027MAGECNuvasive, Inc.PGN2017-09-09
00887517834034MAGECNuvasive, Inc.PGN2017-09-09
00887517834041MAGECNuvasive, Inc.PGN2017-09-09
00856719002114MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00856719002138MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00856719002145MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00856719002152MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00856719002169MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00856719002183MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00856719002190MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00856719002244MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022600MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022617MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022624MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022631MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022648MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022655MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022662MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022679MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022686MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022693MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022709MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258022716MAGEC® Spinal Bracing and Distraction SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2016-01-15
00812258026882MAGEC® Manual DistractorNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2015-12-23
00812258026899MAGEC WandNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2015-12-23
00856719002107External Remote ControllerNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2015-10-15
00812258022242MAGEC® Manual DistractorNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2015-10-15
00812258022259MAGEC WandNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2015-10-15
00812258022723MAGEC® Manual DistractorNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2015-10-15
00812258022839External Remote ControllerNUVASIVE SPECIALIZED ORTHOPEDICS, INC.PGN2015-10-15