FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONVOY Acetabular System
K Number: K213842
·
Decision Oct 3, 2022
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
172
Review Days
298
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Basic Information
- Device Name
- ONVOY Acetabular System
- K Number
- K213842
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Globus Medical, Inc.
- Date Received
- December 9, 2021
- Decision Date
- October 3, 2022
- Product Code
- LPH
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K252166 | RIB LINK Fixation System | Feb 26, 2026 | Substantially Equivalent |
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| K250599 | ExcelsiusGPS Instruments | Nov 5, 2025 | Substantially Equivalent |
| K251161 | ANTHEM® Fracture System | Aug 18, 2025 | Substantially Equivalent |
| K241525 | ExcelsiusXR | Jul 8, 2025 | Substantially Equivalent |
| K243456 | ONVOY Acetabular System | Jun 6, 2025 | Substantially Equivalent |
| K243814 | NuVasive Pulse System | Jan 10, 2025 | Substantially Equivalent |