Identity
- Trade Name
- X-STOP® Interspinous Spacer FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- SPACER 2-4010 X STOP 10MM TRIAL US FDA UDI
- Model / Reference
- 2-4010 FDA UDI
- Description
- SPACER 2-4010 X STOP 10MM TRIAL US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169117662 FDA UDI
- PMA Number
- P040001 FDA UDI
- FDA Product Code
- NQO FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Classification
- Device Class
- Class III 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: Surgical implant/trial-implant/sizer holder, reusable
X-STOP® Interspinous Spacer by Medtronic Sofamor Danek, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant/trial-implant/sizer holder, reusable.
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- ARx — Life Spine, Inc. · Class II
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- JULIET INSTRUMENTATION — Spineart · Class II
- JOURNEY II XR — Smith & Nephew, Inc. · Class II
- TALOS® (HA) IBF — MEDITECH SPINE, LLC · Class II
- BENCOX THR System — Corentec Co., Ltd · Class II
- DISTAL TIBIAL PLATE HANDLE, RIGHT — Biomet Orthopedics, Inc. · Class I
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 |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 3627fb12-fa8f-485d-a5db-8735a87a1829 36 fields · synced Jun 8, 2026