Identity
- Trade Name
- Crescent Spinal System Titanium FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- SPACER 6670936 CRESCENT TI WD 09MMX36MM FDA UDI
- Model / Reference
- 6670936 FDA UDI
- Description
- SPACER 6670936 CRESCENT TI WD 09MMX36MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994849427 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Dimensions & Sizes
- Size
- Outer Diameter — 36.0 Millimeter FDA UDILength — 9.0 Millimeter FDA UDI
Category: General internal orthopaedic fixation system implantation kit
Crescent Spinal System Titanium by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K110543 also covers:
- CRESCENT™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CRESCENT™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CRESCENT™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CRESCENT™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CRESCENT™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CRESCENT™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CRESCENT™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CRESCENT™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CRESCENT™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CRESCENT™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CRESCENT™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CRESCENT™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
K172199 also covers:
- CAPSTONE PTC™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE PTC™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE PTC™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE PTC™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE PTC™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE PTC™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE PTC™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE PTC™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE PTC™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE PTC™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE PTC™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- CAPSTONE PTC™ 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI d0a5d4c8-85a0-48df-86c7-e0960b27bd40 36 fields · synced May 30, 2026