Identity
- Trade Name
- Fathom FDA UDI
- Generic Name
- Orthopaedic implant driver FDA UDI
- Device Name
- Mariner MIS Navigation Shank Driver FDA UDI
- Model / Reference
- MR2-102000 FDA UDI
- Description
- Mariner MIS Navigation Shank Driver FDA UDI
Identifiers
- Catalog Number
- MR2-102000 FDA UDI
- Primary DI / UDI-DI
- 10889981300265 FDA UDI
- 510(k) Number
- K191648 FDA UDI
- FDA Product Code
- NKB FDA UDIOLO FDA UDIKWQ FDA UDI
- GMDN Term
- Orthopaedic implant driver FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI882.4560 FDA UDI888.3060 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
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: Orthopaedic implant driver
Fathom by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K191648 also covers:
- Mariner MIS — SeaSpine Orthopedics Corporation
- Mariner MIS — SeaSpine Orthopedics Corporation
- Mariner MIS — SeaSpine Orthopedics Corporation
- Mariner MIS — SeaSpine Orthopedics Corporation
- Mariner MIS — SeaSpine Orthopedics Corporation
- Mariner MIS — SeaSpine Orthopedics Corporation
- Mariner MIS — SeaSpine Orthopedics Corporation
- Mariner MIS — SeaSpine Orthopedics Corporation
- Mariner MIS — SeaSpine Orthopedics Corporation
- Mariner MIS — SeaSpine Orthopedics Corporation
- Mariner MIS — SeaSpine Orthopedics Corporation
- Mariner MIS — SeaSpine Orthopedics Corporation
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
- SeaSpine Orthopedics Corporation
Sources (1)
- FDA UDI a9c93aaa-10d8-4f22-a1d8-55d05f2b44f9 36 fields · synced Jun 8, 2026