Identity
- Trade Name
- Catalyft PL Expandable Interbody System FDA UDI
- Generic Name
- Stereotactic surgery system probe, reusable FDA UDI
- Device Name
- VERIFICATION TOOL NAV6061013 NAV INSERTR FDA UDI
- Model / Reference
- NAV6061013 FDA UDI
- Description
- VERIFICATION TOOL NAV6061013 NAV INSERTR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000292195 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Stereotactic surgery system probe, 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
Category: Stereotactic surgery system probe, reusable
Catalyft PL Expandable Interbody System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stereotactic surgery system probe, reusable.
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Cleared under the same submission
K210425 also covers:
- Catalyft PL Expandable Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Catalyft PL Expandable Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Catalyft PL Expandable Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Catalyft PL Expandable Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Catalyft PL Expandable Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Catalyft PL Expandable Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Catalyft PL Expandable Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Catalyft PL Expandable Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Catalyft PL Expandable Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Catalyft PL Expandable Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Catalyft PL Expandable Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Catalyft PL Expandable Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
K214011 also covers:
- Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC.
- Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC.
- Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC.
- Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC.
- Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC.
- Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC.
- Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC.
- Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC.
- Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC.
- Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC.
- Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC.
- Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, 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
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI ada208f8-7722-4191-b608-d26191732858 35 fields · synced Jun 8, 2026