Identity
- Trade Name
- Cortium Universal OCT Spinal Fixation System FDA UDI
- Generic Name
- Manual orthopaedic bender, reusable FDA UDI
- Device Name
- In-Situ Rod Bender, Ø4.0mm, Right FDA UDI
- Model / Reference
- UU994-95-41 FDA UDI
- Description
- In-Situ Rod Bender, Ø4.0mm, Right FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810076338217 FDA UDI
- 510(k) Number
- K230614 FDA UDI
- FDA Product Code
- HXW FDA UDI
- GMDN Term
- Manual orthopaedic bender, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
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: Manual orthopaedic bender, reusable
Cortium Universal OCT Spinal Fixation System by Ulrich Medical Usa, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual orthopaedic bender, reusable.
- MESA Small Stature Spinal System — K2M, INC. · Class I
- Invictus — ALPHATEC SPINE, INC. · Class I
- Kestrel® — Innovasis, Inc. · Class II
- Surgical Instrument — OSTEONIC CO., Ltd. · Class I
- Invictus — ALPHATEC SPINE, INC. · Class I
- Dark Star Deformity — Republic Spine, LLC · Class II
- g Source — GSOURCE, LLC. · Class I
- CLAW CHARLOTTE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Ulrich Medical Usa, Inc.
Sources (1)
- FDA UDI 430d6462-c4c7-4f15-85b0-4132dc888da5 35 fields · synced May 30, 2026