Identity
- Trade Name
- SOVEREIGN™ Spinal System FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- TRIAL 9010002077 TRIAL M 37X27 22MM 30 D FDA UDI
- Model / Reference
- 9010002077 FDA UDI
- Description
- TRIAL 9010002077 TRIAL M 37X27 22MM 30 D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169655768 FDA UDI
- 510(k) Number
- K172328 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable 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
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
- Height — 22.0 Millimeter FDA UDILength — 37.0 Millimeter FDA UDIWidth — 27.0 Millimeter FDA UDI
Category: Surgical implant/trial-implant/sizer holder, reusable
SOVEREIGN™ Spinal System by Medtronic Sofamor Danek, Inc. — Class II — 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
K172328 also covers:
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- SOVEREIGN™ 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 b42f5398-4abe-4a88-9bf9-1d0e921d104c 36 fields · synced May 30, 2026