FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)
K Number: K131683
·
Decision Jun 27, 2013
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
3
Review Days
17
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Basic Information
- Device Name
- HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)
- K Number
- K131683
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Depuy Mitek, Inc., A Johnson and Johnson Company
- Date Received
- June 10, 2013
- Decision Date
- June 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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