Identity
- Trade Name
- X-STOP® Interspinous Spacer FDA UDI
- Generic Name
- Lumbar decompression interspinous spacer FDA UDI
- Device Name
- SPACER 1-3206 US 6MM X STOPPK FDA UDISPACER 1-3206 US 6MM X-STOP PEEK FDA UDI
- Model / Reference
- 1-3206 FDA UDI
- Description
- SPACER 1-3206 US 6MM X STOPPK FDA UDISPACER 1-3206 US 6MM X-STOP PEEK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994598714 FDA UDI00643169132856 FDA UDI
- PMA Number
- P040001 FDA UDI
- FDA Product Code
- NQO FDA UDI
- GMDN Term
- Lumbar decompression interspinous spacer FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
MR Conditional FDA UDI
Category: Lumbar decompression interspinous spacer
X-STOP® Interspinous Spacer by Medtronic Sofamor Danek, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Lumbar decompression interspinous spacer.
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Cleared under the same submission
P040001 also covers:
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.
- X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC.
- X-STOP® Interspinous Spacer — 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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (2)
- FDA UDI 50fee1ff-a9c0-4d97-8287-95a2151242ea 36 fields · synced Jun 1, 2026
- FDA UDI ca94d558-9b93-4cbc-8444-9b2ec52c4676 36 fields · synced May 25, 2026