Identity
- Trade Name
- X-STOP® Interspinous Spacer FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- INSERTER 2-2002 UNI WING X STOP INST US FDA UDI
- Model / Reference
- 2-2002 FDA UDI
- Description
- INSERTER 2-2002 UNI WING X STOP INST US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994598561 FDA UDI
- PMA Number
- P040001 FDA UDI
- FDA Product Code
- NQO FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, 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: Orthopaedic inorganic implant inserter/extractor, 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 Orthopaedic inorganic implant inserter/extractor, reusable.
- Omnia Medical Golden Spike — Omnia Medical · Class I
- Calibrate — ALPHATEC SPINE, INC. · Class II
- PAR 5 RING-LOC — Biomet Orthopedics, Inc. · Class I
- Made-To-Order — TORNIER, INC. · Class I
- Vu ePOD™ — SeaSpine Orthopedics Corporation · Class II
- Mariner MCT — SeaSpine Orthopedics Corporation · Class II
- PEEK Corpectomy — Nuvasive, Inc. · Class II
- TIMBERLINE LATERAL FUSION SYSTEM — BIOMET SPINE LLC · Class II
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 (1)
- FDA UDI 799c8a52-51a8-4828-90cd-43d4fdf71702 35 fields · synced May 30, 2026