Identity
- Trade Name
- EXCELSIUSGPS FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- RELINE 4.0mm Tap, Cannulated, FH, GPS FDA UDI
- Model / Reference
- 6252.4041 FDA UDI
- Description
- RELINE 4.0mm Tap, Cannulated, FH, GPS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00193982622541 FDA UDI
- 510(k) Number
- K243671 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Robotic surgical navigation system 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
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
Category: Robotic surgical navigation system
Excelsiusgps by Globus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical navigation system.
- TMINI™ Navigation Console — Think Surgical Inc. · Class II
- VELYS — Medos International Sàrl · Class II
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- OMNIBotics — OMNIlife science, Inc. · Class II
- Cardiodrive System — Stereotaxis, Inc. · Class II
- ExactechGPS — Exactech, Inc. · Class II
- OMNIBotics — OMNIlife science, Inc. · Class II
- REMI Robotic Navigation System — Fusion Robotics, LLC · Class II
Cleared under the same submission
K243671 also covers:
- EXCELSIUSGPS — GLOBUS MEDICAL, INC.
- EXCELSIUSGPS — GLOBUS MEDICAL, INC.
- EXCELSIUSGPS — GLOBUS MEDICAL, INC.
- EXCELSIUSGPS — GLOBUS MEDICAL, INC.
- EXCELSIUSGPS — GLOBUS MEDICAL, INC.
- EXCELSIUSGPS — GLOBUS MEDICAL, INC.
- EXCELSIUSGPS — GLOBUS MEDICAL, INC.
- EXCELSIUSGPS — GLOBUS MEDICAL, INC.
- EXCELSIUSGPS — GLOBUS MEDICAL, INC.
- EXCELSIUSGPS — GLOBUS MEDICAL, INC.
- EXCELSIUSGPS — GLOBUS MEDICAL, INC.
- EXCELSIUSGPS — GLOBUS MEDICAL, 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
- Globus Medical, Inc.
Sources (1)
- FDA UDI dfc27ca6-49c5-4d58-bcae-233dc2882728 34 fields · synced Jun 8, 2026