FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
K Number: K160996
·
Decision Jul 6, 2016
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
6
Review Days
89
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Basic Information
- Device Name
- Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
- K Number
- K160996
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dunamis, LLC
- Date Received
- April 8, 2016
- Decision Date
- July 6, 2016
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Dunamis, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K193245 | Dunamis PunchTac Suture Anchors | Feb 14, 2020 | Substantially Equivalent |
| K191319 | Dunamis Fixation Button System | Aug 29, 2019 | Substantially Equivalent |
| K153746 | Dunamis Force DFX Tensile Tape | Mar 3, 2016 | Substantially Equivalent |
| K151220 | Dunamis Interference Screw | Oct 14, 2015 | Substantially Equivalent |
| K150327 | Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 | Jun 29, 2015 | Substantially Equivalent |