Identity
- Trade Name
- Cortium Universal OCT Spinal Fixation System FDA UDI
- Generic Name
- Spinal bone set screw FDA UDI
- Device Name
- Locking screw for crosslink, screw to screw FDA UDI
- Model / Reference
- UU071-71-0001 FDA UDI
- Description
- Locking screw for crosslink, screw to screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814386028202 FDA UDI
- 510(k) Number
- K230614 FDA UDI
- FDA Product Code
- NKG FDA UDI
- GMDN Term
- Spinal bone set screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
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: Spinal bone set screw
Cortium Universal OCT Spinal Fixation System by Ulrich Medical Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230614 also covers:
- Cortium Universal OCT Spinal Fixation System — ULRICH MEDICAL USA, INC.
- Cortium Universal OCT Spinal Fixation System — ULRICH MEDICAL USA, INC.
- Cortium Universal OCT Spinal Fixation System — ULRICH MEDICAL USA, INC.
- Cortium Universal OCT Spinal Fixation System — ULRICH MEDICAL USA, INC.
- Cortium Universal OCT Spinal Fixation System — ULRICH MEDICAL USA, INC.
- Cortium Universal OCT Spinal Fixation System — ULRICH MEDICAL USA, INC.
- Cortium Universal OCT Spinal Fixation System — ULRICH MEDICAL USA, INC.
- Cortium Universal OCT Spinal Fixation System — ULRICH MEDICAL USA, INC.
- Cortium Universal OCT Spinal Fixation System — ULRICH MEDICAL USA, INC.
- Cortium Universal OCT Spinal Fixation System — ULRICH MEDICAL USA, INC.
- Cortium Universal OCT Spinal Fixation System — ULRICH MEDICAL USA, INC.
- Cortium Universal OCT Spinal Fixation System — ULRICH MEDICAL USA, INC.
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
- Ulrich Medical Usa, Inc.
Sources (1)
- FDA UDI 38c77997-390a-402c-af51-575696203ae4 35 fields · synced Jun 8, 2026