Identity
- Trade Name
- TSRH® Spinal System FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- PLATE 810-402 XLINK LP 1/4 INCH LEN .750 FDA UDI
- Model / Reference
- 810-402 FDA UDI
- Description
- PLATE 810-402 XLINK LP 1/4 INCH LEN .750 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00673978042442 FDA UDI
- 510(k) Number
- K870830 FDA UDI
- FDA Product Code
- KWP FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 0.75 Inch FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
TSRH® Spinal System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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Cleared under the same submission
K870830 also covers:
- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC.
- TSRH® 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 37513415-df5b-4260-a01a-ef357030c8a9 36 fields · synced May 30, 2026