FDA.reportPublic FDA data

MAGEC® Manual Distractor

Primary DI
00812258026882
Brand
MAGEC® Manual Distractor
Company
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Model
MMD-001-U
Catalog number
MMD-001-U
Device description
Manual distractor - for use with the MAGEC® Spinal Bracing and Distraction System
Published
2015-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812258026882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812258026882008122580268828122580268820812258026882

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-435-5477csdepartment@ellipse-tech.com
866-456-2871info@globusmedical.com

Regulatory Flags#

DUNS number
837845234
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
00887517952219PRECICE® STRYDE SystemSST-010-000SST-010-0002018-10-19
00887517952226PRECICE® STRYDE SystemSST-010-005SST-010-0052018-10-19
00887517952233PRECICE® STRYDE SystemSST-010-010SST-010-0102018-10-19
00887517952240PRECICE® STRYDE SystemSST-010-015SST-010-0152018-10-19
00887517952257PRECICE® STRYDE SystemSST-010-020SST-010-0202018-10-19
00887517952264PRECICE® STRYDE SystemSST-013-000SST-013-0002018-10-19
00887517952271PRECICE® STRYDE SystemSST-013-005SST-013-0052018-10-19
00887517952288PRECICE® STRYDE SystemSST-013-010SST-013-0102018-10-19
00887517952295PRECICE® STRYDE SystemSST-013-015SST-013-0152018-10-19
00887517952301PRECICE® STRYDE SystemSST-013-020SST-013-0202018-10-19
00887517001139PRECICE® Intramedullary Limb Lengthening SystemCPA2-000CPA2-0002017-10-10
00887517001146PRECICE® Intramedullary Limb Lengthening SystemCPA2-005CPA2-0052017-10-10
00887517001153PRECICE® Intramedullary Limb Lengthening SystemCPA2-010CPA2-0102017-10-10
00887517001160PRECICE® Intramedullary Limb Lengthening SystemCPA2-015CPA2-0152017-10-10
00887517001177PRECICE® Intramedullary Limb Lengthening SystemCPA2-020CPA2-0202017-10-10
00887517001184PRECICE® Intramedullary Limb Lengthening SystemCPA3-000CPA3-0002017-10-10
00887517001191PRECICE® Intramedullary Limb Lengthening SystemCPA3-005CPA3-0052017-10-10
00887517001207PRECICE® Intramedullary Limb Lengthening SystemCPA3-010CPA3-0102017-10-10
00887517001214PRECICE® Intramedullary Limb Lengthening SystemCPA3-015CPA3-0152017-10-10
00887517001221PRECICE® Intramedullary Limb Lengthening SystemCPA3-020CPA3-0202017-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887517834010MAGECNuvasive, Inc.PGN2017-09-09
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
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