FDA.reportPublic FDA data

Minimally Invasive Deformity Correction (MID-C) System

Primary DI
07290018128015
Brand
Minimally Invasive Deformity Correction (MID-C) System
Company
APIFIX LTD
Model
MID-C 95
Published
2020-05-24
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
QGPPosterior Ratcheting Rod System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGPPosterior Ratcheting Rod SystemUnknownN

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H170001002

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H170001002

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018128015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018128015072900181280157290018128015

GMDN Terms#

Term, Definition table
TermDefinition
Spinal dynamic-stabilization systemA sterile bone screw spinal implant assembly intended to be used for spinal dynamic stabilization (i.e., soft stabilization), a surgical method different from spinal fixation in that it allows slight mobility between the unstable vertebral segments in the spine. It consists of a combination of pedicle screws, spacers, and a flexible synthetic polymer cord and titanium (Ti) rods used as the longitudinal member; conventional and specialized surgical instruments may also be included. The system is intended to treat various lumbar, thoracic, and/or sacral spinal instabilities and deformities (e.g., degenerative spondylolisthesis, pseudoarthrosis) typically as an adjunct to spinal fusion.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
649220688
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
07290018128411Minimally Invasive Deformity Correction (MID-C) SystemExtender- Lenke 1 LeftEUS-055-0022021-06-29
07290018128008Minimally Invasive Deformity Correction (MID-C) SystemMID-C 85 2020-05-24
07290018128022Minimally Invasive Deformity Correction (MID-C) SystemMID-C 105 2020-05-24
07290018128039Minimally Invasive Deformity Correction (MID-C) SystemMID-C 115 2020-05-24
07290018128046Minimally Invasive Deformity Correction (MID-C) SystemMID-C 1252020-05-24
07290018128374Minimally Invasive Deformity Correction (MID-C) SystemExtender - Lenke 52020-05-24
07290018128381Minimally Invasive Deformity Correction (MID-C) SystemExtender - Lenke 12020-05-24
07290014993808Minimally Invasive Deformity Correction (MID-C) SystemMID-C Surgical Instruments KitAFT-100-0002020-05-24
07290018128398Minimally Invasive Deformity Correction (MID-C) SystemTUS-022-STR2020-10-28
07290018128404Minimally Invasive Deformity Correction (MID-C) SystemTUS-023-STR2020-10-28
07290018128053Minimally Invasive Deformity Correction (MID-C) SystemScrew 5.0 X 302020-05-24
07290018128060Minimally Invasive Deformity Correction (MID-C) SystemScrew 5.0 X 352020-05-24
07290018128077Minimally Invasive Deformity Correction (MID-C) SystemScrew 5.5 X 302020-05-24
07290018128084Minimally Invasive Deformity Correction (MID-C) SystemScrew 5.5 X 352020-05-24
07290018128091Minimally Invasive Deformity Correction (MID-C) SystemScrew 5.5 X 40 2020-05-24
07290018128107Minimally Invasive Deformity Correction (MID-C) SystemScrew 5.5 X 45 2020-05-24
07290018128114Minimally Invasive Deformity Correction (MID-C) SystemScrew 6.0 X 352020-05-24
07290018128121Minimally Invasive Deformity Correction (MID-C) SystemScrew 6.0 X 402020-05-24
07290018128138Minimally Invasive Deformity Correction (MID-C) SystemScrew 6.0 X 452020-05-24
07290018128145Minimally Invasive Deformity Correction (MID-C) SystemScrew 6.5 X 35 2020-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290018128411Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2021-06-29
07290018128398Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-10-28
07290018128404Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-10-28
07290018128312Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-25
07290014993808Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128008Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128022Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128039Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128046Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128053Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128060Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128077Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128084Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128091Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128107Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128114Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128121Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128138Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128145Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128152Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128169Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128176Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128183Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128190Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128206Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128213Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128220Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128237Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128244Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24
07290018128251Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDQGP2020-05-24