FDA UDI
In Commercial Distribution
🇺🇸 United States
Minimally Invasive Deformity Correction (MID-C) System
DI: 07290018128411
·
Model: Extender- Lenke 1 Left
·
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
- 07290018128411
- Version / Model
- Extender- Lenke 1 Left
- Catalog Number
- EUS-055-002
- Company Name
- APIFIX LTD
- Labeler DUNS
- 649220688
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-29
- Public Version
- 4
- Public Version Date
- 2026-04-24
- Public Version Status
- Update
- Public Device Record Key
- 4698f888-6498-418c-a950-64782fae6996
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 |
|---|---|---|---|---|
| 67285 | Spinal rachet-distraction rod extender | An implantable, metallic device in the form of a short, fixed length rod intended to be optionally connected to the upper end of a mechanical rachet-based spinal distraction rod (not included) to increase its length to provide greater load distribution (e.g., when the patient has small pedicles) as part of scoliosis treatment. It is not intended to be implanted without the parent rod. It has a U-shaped end, which may be straight or angled, to allow connection to the parent rod; it is designed to be fixed to the parent rod and vertebrae using bone screws. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290018128411 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H170001 | 003 |