FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Fusion Silastic System
K Number: K190136
·
Decision Oct 21, 2019
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
20
Applicant Total
11
Review Days
265
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Basic Information
- Device Name
- Fusion Silastic System
- K Number
- K190136
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3720
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fusion Orthopedics, LLC
- Date Received
- January 29, 2019
- Decision Date
- October 21, 2019
- Product Code
- KWH
- 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 |
|---|---|---|---|
| KWH | Prosthesis, Toe, Constrained, Polymer | FDA class 2 | Orthopedic |
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Other Clearances by Fusion Orthopedics, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K210159 | IntraLock System | Jul 23, 2021 | Substantially Equivalent |
| K193377 | TopLock Anchor System | Nov 25, 2020 | Substantially Equivalent |
| K202959 | PolyLock Plating System | Nov 24, 2020 | Substantially Equivalent |
| K192323 | PolyLock Small Bone Plating System | Nov 18, 2019 | Substantially Equivalent |
| K182342 | IntraLock Lapidus System | May 21, 2019 | Substantially Equivalent |
| K182684 | HammerTechTM Fixation System | Nov 23, 2018 | Substantially Equivalent |
| K181815 | DynaBridge | Oct 15, 2018 | Substantially Equivalent |
| K170624 | TalarLift STS | Aug 11, 2017 | Substantially Equivalent |
| K170038 | FuzeFix Screw System | Aug 7, 2017 | Substantially Equivalent |
| K161449 | HammerTech Fixation System | Oct 11, 2016 | Substantially Equivalent |