AccessGUDID - DEVICE: Minimally Invasive Deformity Correction (MID-C) System (07290018128046)

GUDID

Device Identifier (DI) Information

Brand Name: Minimally Invasive Deformity Correction (MID-C) System
Version or Model: MID-C 125
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APIFIX LTD

Primary DI Number: 07290018128046
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649220688 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
67286	Spinal distraction rod, mechanical	An implantable, mechanical (non-electric, non-magnetic), metallic rod, capable of adjusting in length, designed to be fixed alongside the spinal column enabling periodic lengthening to distract the spine and provide adequate bracing during growth to minimize the progression of scoliosis. It incorporates a rachet-based mechanism that allows noninvasive, post-implantation lengthening during patient growth and/or correction of scoliosis (i.e., self-lengthens in situ). It is fixed to the vertebrae using two pedicle bone screws at its ends, which may be included with the rod.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QGP	Posterior Ratcheting Rod System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H170001	002

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d9ac3a75-e5a7-41c8-b91c-d307399fa0dc
Public Version Date: September 02, 2024
Public Version Number: 3
DI Record Publish Date: May 24, 2020