FDA UDI
In Commercial Distribution
🇺🇸 United States
Orthofix TrueLok Hexapod System (TL-HEX) V2.0
DI: 18053800895955
·
Model: 1
·
ORTHOFIX SRL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Orthofix TrueLok Hexapod System (TL-HEX) V2.0
- Primary DI
- 18053800895955
- Version / Model
- 1
- Catalog Number
- 56-14140
- Company Name
- ORTHOFIX SRL
- Labeler DUNS
- 438793622
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-15
- Public Version
- 1
- Public Version Date
- 2026-04-23
- Public Version Status
- New
- Public Device Record Key
- dd77fbaf-1ae1-44db-bcba-307dbcfa0e4b
Device Description
TRUELOK PLUS FOREFOOT REDUCTION ARCH 140MM
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
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | Orthopedic | 888.3030 | 2 |
| OSN | Software for diagnosis/treatment | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67571 | External orthopaedic fixation system noninvasive component, single-use | A noninvasive structural component of an external orthopaedic fixation system intended for bone/joint fracture stabilization in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18053800895955 | GS1 |
Customer Contacts
- Phone
- +0390456719000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170650 | 000 |