FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ActiFlip
K Number: K212739
·
Decision Oct 6, 2021
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
28
Review Days
37
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Basic Information
- Device Name
- ActiFlip
- K Number
- K212739
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Parcus Medical, LLC
- Date Received
- August 30, 2021
- Decision Date
- October 6, 2021
- 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 Parcus Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K221502 | Parcus Synd-EZ SS | Jul 26, 2022 | Substantially Equivalent |
| K221135 | X-Twist PEEK Suture Anchor | May 19, 2022 | Substantially Equivalent |
| K202662 | Parcus Titanium Interference Screws | Feb 22, 2021 | Substantially Equivalent |
| K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip | Oct 28, 2020 | Substantially Equivalent |
| K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors | Jul 23, 2020 | Substantially Equivalent |
| K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor | Jan 23, 2020 | Substantially Equivalent |
| K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip | Jan 16, 2020 | Substantially Equivalent |
| K192964 | Parcus Synd-EZ SS | Nov 22, 2019 | Substantially Equivalent |
| K192824 | Parcus Knotless AP Suture Anchors | Nov 2, 2019 | Substantially Equivalent |
| K191783 | Parcus Synd-EZ Ti | Oct 9, 2019 | Substantially Equivalent |