Identity
- Trade Name
- XULTAN IN-SITU BENDER LEFT FDA UDI
- Generic Name
- Manual orthopaedic bender, reusable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 30290320 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 30290320 FDA UDI
- Primary DI / UDI-DI
- 00819824023641 FDA UDI
- 510(k) Number
- K170108 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Manual orthopaedic bender, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual orthopaedic bender, reusable
Xultan In-Situ Bender Left by Met 1 Technologies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K170108 also covers:
- XULTAN 5.5 PEDICLE CROSSLINK 28-30 MM — MET 1 TECHNOLOGIES, LLC
- XULTAN 5.5 PEDICLE CROSSLINK 50-60 MM — MET 1 TECHNOLOGIES, LLC
- XULTAN 5.5 PEDICLE ROD 100 MM BENT — MET 1 TECHNOLOGIES, LLC
- XULTAN 5.5 PEDICLE ROD 50 MM BENT — MET 1 TECHNOLOGIES, LLC
- XULTAN 5.5 PEDICLE ROD 500 MM STRAIGHT — MET 1 TECHNOLOGIES, LLC
- XULTAN 5.5 PEDICLE ROD 60 MM STRAIGHT — MET 1 TECHNOLOGIES, LLC
- XULTAN 5.5 PEDICLE ROD 75 MM STRAIGHT — MET 1 TECHNOLOGIES, LLC
- XULTAN 5.5 PEDICLE ROD 80 MM BENT — MET 1 TECHNOLOGIES, LLC
- XULTAN 5.5 PEDICLE ROD 80 MM STRAIGHT — MET 1 TECHNOLOGIES, LLC
- XULTAN 5.5 PEDICLE ROD 95 MM STRAIGHT — MET 1 TECHNOLOGIES, LLC
- XULTAN 5.5 PEDICLE SCREW 4.5 X 30 MM NON-CANN — MET 1 TECHNOLOGIES, LLC
- XULTAN 5.5 PEDICLE SCREW 4.5 X 40 MM NON-CANN — MET 1 TECHNOLOGIES, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Met 1 Technologies, Llc
Sources (1)
- FDA UDI 056d112b-71f8-4aeb-aae9-00c89d0354e5 36 fields · synced May 30, 2026