FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HammerTechTM Fixation System
K Number: K182684
·
Decision Nov 23, 2018
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
11
Review Days
58
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Basic Information
- Device Name
- HammerTechTM Fixation System
- K Number
- K182684
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fusion Orthopedics, LLC
- Date Received
- September 26, 2018
- Decision Date
- November 23, 2018
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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| K170624 | TalarLift STS | Aug 11, 2017 | Substantially Equivalent |
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| K161449 | HammerTech Fixation System | Oct 11, 2016 | Substantially Equivalent |