FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PARCUS PEEK CF PUSH-IN SUTURE ANCHOR
K Number: K102162
·
Decision Nov 10, 2010
Classifications
1
FEI Numbers
653
Registration Numbers
653
Same Product Code
1040
Applicant Total
14
Review Days
100
Basic Information
- Device Name
- PARCUS PEEK CF PUSH-IN SUTURE ANCHOR
- K Number
- K102162
- 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 2, 2010
- Decision Date
- November 10, 2010
- 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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Other Clearances by PARCUS MEDICAL, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K162198 | GFS Ultimate | Nov 18, 2016 | Substantially Equivalent |
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| K133757 | GFS II STANDARD, GFS II LARGE, GFS MIMI | Feb 4, 2014 | Substantially Equivalent |
| K122805 | PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR | Feb 5, 2013 | Substantially Equivalent |
| K120942 | PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC | Apr 20, 2012 | Substantially Equivalent |
| K113730 | PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS | Jan 17, 2012 | Substantially Equivalent |
| K111000 | PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR | Jul 28, 2011 | Substantially Equivalent |
| K102326 | PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR | Nov 15, 2010 | Substantially Equivalent |
| K091094 | PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264 | Sep 30, 2009 | Substantially Equivalent |
| K091093 | PARCUS PPEK CF INTERFERENCE SCREW | Sep 30, 2009 | Substantially Equivalent |