FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ExcelsiusXR
K Number: K241525
·
Decision Jul 8, 2025
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
41
Applicant Total
172
Review Days
404
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Basic Information
- Device Name
- ExcelsiusXR
- K Number
- K241525
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Globus Medical, Inc.
- Date Received
- May 30, 2024
- Decision Date
- July 8, 2025
- Product Code
- SBF
- Advisory Committee
- Neurology
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SBF | Orthopedic Augmented Reality | FDA class 2 | Neurology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K261043 | AUTOBAHN Nailing System | Apr 24, 2026 | Substantially Equivalent |
| K252166 | RIB LINK Fixation System | Feb 26, 2026 | Substantially Equivalent |
| K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | Dec 22, 2025 | Substantially Equivalent |
| K250599 | ExcelsiusGPS Instruments | Nov 5, 2025 | Substantially Equivalent |
| K251161 | ANTHEM® Fracture System | Aug 18, 2025 | Substantially Equivalent |
| K243456 | ONVOY Acetabular System | Jun 6, 2025 | Substantially Equivalent |
| K243814 | NuVasive Pulse System | Jan 10, 2025 | Substantially Equivalent |
| K243671 | ExcelsiusGPS® Instruments | Dec 20, 2024 | Substantially Equivalent |