FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
Stern Fix Sternal Stabilization System
K Number: K211613
·
Decision Jan 19, 2022
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
128
Applicant Total
6
Review Days
238
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Basic Information
- Device Name
- Stern Fix Sternal Stabilization System
- K Number
- K211613
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neos Surgery S.L
- Date Received
- May 26, 2021
- Decision Date
- January 19, 2022
- Product Code
- JDQ
- 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Neos Surgery S.L
| K Number | Device Name | ||
|---|---|---|---|
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | Feb 16, 2024 | Substantially Equivalent |
| K221795 | STERN FIX Sternal Stabilization System | Oct 19, 2022 | Substantially Equivalent |
| K160739 | Cranial COVER | Jun 12, 2016 | Substantially Equivalent |
| K132044 | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM | Sep 30, 2013 | Substantially Equivalent |
| K101235 | CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM | Oct 25, 2010 | Substantially Equivalent |