FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR
K Number: K130196
·
Decision Feb 27, 2013
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
112
Review Days
30
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Basic Information
- Device Name
- SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR
- K Number
- K130196
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrocare Corp.
- Date Received
- January 28, 2013
- Decision Date
- February 27, 2013
- 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 Arthrocare Corp.
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|---|---|---|---|
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| K111397 | TITAN TI SUTURE ANCHOR SYSTEM | Jul 12, 2011 | Substantially Equivalent |
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| K110183 | ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE | Feb 16, 2011 | Substantially Equivalent |
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| K101437 | SPEEDFIX SUTURE SYSTEM | Oct 29, 2010 | Substantially Equivalent |
| K102262 | ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL | Oct 21, 2010 | Substantially Equivalent |
| K100479 | PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE | Sep 21, 2010 | Substantially Equivalent |