FDA UDI
In Commercial Distribution
🇺🇸 United States
XULTAN IN-SITU BENDER LEFT
DI: 00819824023641
·
Model: 30290320
·
MET 1 TECHNOLOGIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- XULTAN IN-SITU BENDER LEFT
- Primary DI
- 00819824023641
- Version / Model
- 30290320
- Catalog Number
- 30290320
- Company Name
- MET 1 TECHNOLOGIES, LLC
- Labeler DUNS
- 080474650
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-30
- Public Version
- 4
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- 056d112b-71f8-4aeb-aae9-00c89d0354e5
Device Description
THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44795 | Manual orthopaedic bender, reusable | A manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. It is typically in the form of pliers, a rod-like (e.g., pin) or bench-top device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819824023641 | GS1 |
Customer Contacts
- Phone
- 9154726762
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170108 | 000 |