Identity
- Trade Name
- Navigation FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Cannulated Tap, 4.5 FDA UDI
- Model / Reference
- 16-02-01-1 FDA UDI
- Description
- Cannulated Tap, 4.5 FDA UDI
Identifiers
- Catalog Number
- 161-0002 FDA UDI
- Primary DI / UDI-DI
- M7401610002 FDA UDI
- 510(k) Number
- K180796 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.5 Millimeter FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
Navigation by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K180796 also covers:
- Navigation — SPINEOLOGY INC.
- Navigation — SPINEOLOGY INC.
- Navigation — SPINEOLOGY INC.
- Navigation — SPINEOLOGY INC.
- Navigation — SPINEOLOGY INC.
- Navigation — SPINEOLOGY INC.
- Navigation — SPINEOLOGY INC.
- Navigation — SPINEOLOGY INC.
- Navigation — SPINEOLOGY INC.
- Navigation — SPINEOLOGY INC.
- Navigation — SPINEOLOGY INC.
- Navigation — SPINEOLOGY 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
- Spineology Inc.
Sources (1)
- FDA UDI bb54f972-8258-4afa-884b-0e8595a0777f 37 fields · synced Jun 6, 2026