Identity
- Trade Name
- Threshold Pedicular Fixation System FDA UDI
- Generic Name
- Post-PCR cleanup kit IVD FDA UDI
- Device Name
- Fixed Rod Holder FDA UDI
- Model / Reference
- 53-17-01 FDA UDI
- Description
- Fixed Rod Holder FDA UDI
Identifiers
- Catalog Number
- 530-0094 FDA UDI
- Primary DI / UDI-DI
- M7405300094 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Post-PCR cleanup kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
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
MR Unsafe FDA UDI
Category: Post-PCR cleanup kit IVD
Threshold Pedicular Fixation System by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Post-PCR cleanup kit IVD.
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- ViroSeq — Abbott Molecular · Class I
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Spineology Inc.
Sources (1)
- FDA UDI 680de8d2-e760-4a50-80a9-e6d36db5be82 35 fields · synced Jun 1, 2026