FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REVERE STABILIZATION SYSTEM
K Number: K061202
·
Decision Jul 20, 2006
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
172
Review Days
80
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Basic Information
- Device Name
- REVERE STABILIZATION SYSTEM
- K Number
- K061202
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Globus Medical, Inc.
- Date Received
- May 1, 2006
- Decision Date
- July 20, 2006
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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Other Clearances by Globus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System | May 7, 2026 | Substantially Equivalent |
| K253401 | SCRIPT Implant System | Apr 29, 2026 | Substantially Equivalent |
| 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 |
| 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 |