Identity
- Trade Name
- Cortium Universal OCT Spinal Fixation System FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- Drill, Ø 2.4mm, AO coupling, single use FDA UDI
- Model / Reference
- UU072-15-0024 FDA UDI
- Description
- Drill, Ø 2.4mm, AO coupling, single use FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814386028363 FDA UDI
- 510(k) Number
- K230614 FDA UDI
- FDA Product Code
- NKG FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use 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
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: Fluted surgical drill bit, single-use
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 0c0fa159-cf45-4e86-8e52-cf77a817ded9 35 fields · synced Jun 8, 2026