FDA UDI
In Commercial Distribution
🇺🇸 United States
Tritium Sternal Cable Plate System
DI: 00191083005522
·
Model: 86-250
·
Rti Surgical, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tritium Sternal Cable Plate System
- Primary DI
- 00191083005522
- Version / Model
- 86-250
- Catalog Number
- 86-250
- Company Name
- Rti Surgical, Inc.
- Labeler DUNS
- 117560455
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-12
- Public Version
- 5
- Public Version Date
- 2023-10-19
- Public Version Status
- Update
- Public Device Record Key
- a23ea29b-fbbc-4b50-8602-f70af6dd5710
Device Description
X Plate Without Cable
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
- 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 |
|---|---|---|---|---|
| JDQ | Cerclage, fixation | Orthopedic | 888.3010 | 2 |
| HWC | Screw, fixation, bone | Orthopedic | 888.3040 | 2 |
| HRS | Plate, fixation, bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34017 | Sternal fixation device | A collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191083005522 | GS1 |
Customer Contacts
- Phone
- +1(386)418-8888
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150581 | 000 |