FDA UDI
In Commercial Distribution
🇺🇸 United States
Fixone Meniscal Repair
DI: 08800039101226
·
Model: FMC-14665d
·
AJU PHARM. CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fixone Meniscal Repair
- Primary DI
- 08800039101226
- Version / Model
- FMC-14665d
- Company Name
- AJU PHARM. CO., LTD.
- Labeler DUNS
- 963422810
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-06
- Public Version
- 1
- Public Version Date
- 2025-01-14
- Public Version Status
- New
- Public Device Record Key
- 9b366c77-412d-49c9-914a-85e9bd4d4c21
Device Description
The Fixone Meniscal Repair are all-inside meniscal repair devices. Each device includes two peek anchors, pre-tied with non-absorbable suture pre-loaded into a needle delivery system with an adjustable length depth limiter. The device is made to insert into the joint, place and fix the first anchor(T1) around the ruptured meniscus cartilage, and then place and fix the second anchor(T2) to make one Stitch to seal the torn cartilage. The device is provided sterile for single use only.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45062 | Tendon/ligament bone anchor, non-bioabsorbable | A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800039101226 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233601 | 000 |