Identity
- Trade Name
- Linkt FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Linkt Staple Instrument Kit - 15mm FDA UDI
- Model / Reference
- SK15 FDA UDI
- Description
- Linkt Staple Instrument Kit - 15mm FDA UDI
Identifiers
- Catalog Number
- SK15 FDA UDI
- Primary DI / UDI-DI
- 00810146163930 FDA UDI
- FDA Product Code
- OJH FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General internal orthopaedic fixation system implantation kit
Linkt by Trax Surgical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- OsteoMed — Osteomed Corp. · Class II
- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · 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
- Trax Surgical
Sources (1)
- FDA UDI 13e963f9-b86a-46f0-9c86-d69511c893e4 34 fields · synced Jun 1, 2026