FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Responsive Arthroscopy Wedge Push-In Suture Anchors
K Number: K190446
·
Decision Mar 27, 2019
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
11
Review Days
30
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Basic Information
- Device Name
- Responsive Arthroscopy Wedge Push-In Suture Anchors
- K Number
- K190446
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Responsive Arthroscopy, LLC
- Date Received
- February 25, 2019
- Decision Date
- March 27, 2019
- 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 Responsive Arthroscopy, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K253010 | Mini Superhawk Suture Anchor System | Oct 14, 2025 | Substantially Equivalent |
| K233258 | Shadow Knotless All-Suture Anchors | Oct 23, 2023 | Substantially Equivalent |
| K230094 | Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors | Aug 25, 2023 | Substantially Equivalent |
| K222763 | Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors | Oct 13, 2022 | Substantially Equivalent |
| K203121 | Responsive Arthroscopy Thunderbolt System | Apr 27, 2021 | Substantially Equivalent |
| K202569 | Responsive Arthroscopy Interference Screw System | Sep 23, 2020 | Substantially Equivalent |
| K202153 | Responsive Arthroscopy Suture Anchor System | Sep 9, 2020 | Substantially Equivalent |
| K181076 | Responsive Arthroscopy Wedge Push-In Suture Anchors | Jan 18, 2019 | Substantially Equivalent |
| K180951 | Responsive Arthroscopy Suture Anchor System | Jan 3, 2019 | Substantially Equivalent |
| K180573 | Responsive Arthroscopy Interference Screw System | Nov 23, 2018 | Substantially Equivalent |