FDA UDI
In Commercial Distribution
🇺🇸 United States
FITBONE TAA SYSTEM
DI: 18053340344012
·
Model: 1
·
ORTHOFIX SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FITBONE TAA SYSTEM
- Primary DI
- 18053340344012
- Version / Model
- 1
- Catalog Number
- 60001445
- Company Name
- ORTHOFIX SRL
- Labeler DUNS
- 438793622
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-14
- Public Version
- 2
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 70e572b4-8688-4e52-93ad-f50499063fd1
Device Description
FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1160-T-225
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63191 | Long bone distraction nail, motorized | An implantable, electrically-powered device in the form of a rod, capable of extending in length, designed to be inserted into the medullary cavity of a long bone to hold the ends of a fractured bone in position to promote healing, or to correct limb length discrepancies. A rod (nail) is specific to a particular long bone (e.g., femur, humerus, tibia) and is used for traumatic repair or reconstructive procedures (e.g., leg lengthening). It consists of telescoping rods connected to the bone by locking screws, and a small motor to provide lengthening force which is controlled/powered by a remote controller device operating through an implanted receiver. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18053340344012 | GS1 |
Customer Contacts
- Phone
- +0390456719000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163368 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 11 | Millimeter | |
| Length | 60 | Millimeter | |
| Length | 225 | Millimeter |