Identity
- Trade Name
- LYNX FDA UDI
- Generic Name
- Orthopaedic bone bolt FDA UDI
- Device Name
- LYNX ø3.5mm Distance Bolt, Ti FDA UDI
- Model / Reference
- HTR-02-600110 FDA UDI
- Description
- LYNX ø3.5mm Distance Bolt, Ti FDA UDI
Identifiers
- Catalog Number
- HTR-02-600110 FDA UDI
- Primary DI / UDI-DI
- 00841742111292 FDA UDI
- 510(k) Number
- K102845 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Orthopaedic bone bolt FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
No
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
MR Safe FDA UDI
Category: Orthopaedic bone bolt
Lynx by Hnm Total Recon Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102845 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hnm Total Recon Llc
Sources (1)
- FDA UDI be62370f-1a42-4245-a3d9-cb339547f02a 35 fields · synced May 30, 2026