Identity
- Trade Name
- CD HORIZON Spinal System FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- TAP 6641070 7.0MM CANNULATED DUAL LEAD FDA UDI
- Model / Reference
- 6641070 FDA UDI
- Description
- TAP 6641070 7.0MM CANNULATED DUAL LEAD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169576797 FDA UDI
- 510(k) Number
- K153463 FDA UDI
- FDA Product Code
- KWP FDA UDINKB FDA UDIMNI FDA UDIHWE FDA UDIMNH FDA UDIKWQ FDA UDIOSH FDA UDI
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3070 FDA UDI878.4820 FDA UDI888.3060 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
Dimensions & Sizes
- Size
- Outer Diameter — 7.0 Millimeter FDA UDI
Category: Fluted surgical drill bit, reusable
CD HORIZON Spinal System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluted surgical drill bit, reusable.
- RingLoc® + — Biomet Orthopedics, Inc. · Class I
- DLC Cortical Bone Drill 5.7mmD Implant — IMPLANT DIRECT SYBRON MANUFACTURING LLC · Class II
- MatrixMANDIBLE — Synthes · Class II
- Brasseler — SUNCOAST DENTAL, INC. · Class I
- ROTACYJNE NARZĘDZIA CHIRURGICZNE — ChM spółka z ograniczoną odpowiedzialnością · Class IIa
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- Revision Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class I
- Straight Twist Drill — DENTIS CO. , LTD · Class I
Cleared under the same submission
K153463 also covers:
- CD HORIZON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CD HORIZON Spinal System — MEDTRONIC SOFAMOR DANEK, 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
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI dc113d75-6d6d-461d-a972-e3022f8db3d4 36 fields · synced May 30, 2026