FDA UDI
In Commercial Distribution
🇺🇸 United States
Minimally Invasive Deformity Correction (MID-C) System
DI: 07290018128015
·
Model: MID-C 95
·
APIFIX LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Minimally Invasive Deformity Correction (MID-C) System
- Primary DI
- 07290018128015
- Version / Model
- MID-C 95
- Company Name
- APIFIX LTD
- Labeler DUNS
- 649220688
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-24
- Public Version
- 5
- Public Version Date
- 2026-04-24
- Public Version Status
- Update
- Public Device Record Key
- f4bf4310-a45c-4c8f-b6f5-bbd5d97466e8
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QGP | Posterior Ratcheting Rod System | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67286 | Spinal rachet-distraction rod | 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290018128015 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H170001 | 002 |