FDA UDI
In Commercial Distribution
🇺🇸 United States
Fixone All Suture Anchor
DI: 08800039100502
·
Model: FAF-24615802ig
·
AJU PHARM. CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fixone All Suture Anchor
- Primary DI
- 08800039100502
- Version / Model
- FAF-24615802ig
- 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
- 0689b4f4-1ede-455e-8469-c5ab2695ca96
Device Description
Fixone All suture anchor consists of one “fix Suture” and one,two or three non-absorbable Sutures. The non-absorbable suture is manufactured from UHMWPE. They are pre-loaded on a handled insertion device. This device isprovided sterile, for single use only. This device is medical device. Prescription 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 | 08800039100502 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222423 | 000 |