Identity
- Trade Name
- TSRH® Spinal System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- HOOK 88900105 5.5 RHT PED W OUT SCREW TI FDA UDI
- Model / Reference
- 88900105 FDA UDI
- Description
- HOOK 88900105 5.5 RHT PED W OUT SCREW TI FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885074457772 FDA UDI
- 510(k) Number
- K052144 FDA UDI
- FDA Product Code
- NKB FDA UDIKWP FDA UDIMNI FDA UDIKWQ FDA UDIMNH FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system hook FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI888.3060 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
Category: Bone-screw internal spinal fixation system hook
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 Bone-screw internal spinal fixation system hook.
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- ReLine — Nuvasive, Inc. · Class II
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Cleared under the same submission
K052144 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 63c67b4a-d969-4ccc-8dda-3df27369907c 35 fields · synced Jun 6, 2026